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D001930: Brain Injuries

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO

Correlated Drug Terms (39)

Name (Synonyms) Correlation
drug776 Chloroquine Wiki 0.46
drug783 Chloroquine or hydroxychloroquine Wiki 0.43
drug338 Attention Control Group Wiki 0.30
Name (Synonyms) Correlation
drug3741 YinHu QingWen Decoction(low dose) Wiki 0.30
drug752 Certified cloth face mask plus preventive information Wiki 0.30
drug2661 Prolonged Exposure (PE) Wiki 0.30
drug4176 zinc Wiki 0.30
drug774 Chinese medicine treatment Wiki 0.30
drug2836 Reconsolidation of Traumatic Memories (RTM) Wiki 0.30
drug1958 Magnetic Resonance Spectroscopy (MRS). Wiki 0.30
drug501 Blink and Masseter Inhibitory Reflex Wiki 0.30
drug4125 standard western medicine treatment Wiki 0.30
drug2644 Preventive information Wiki 0.30
drug1409 Graded exposure therapy Wiki 0.30
drug343 Auditory Evoked Potentials (AEP) Wiki 0.30
drug2092 Morning Bright Light Therapy Wiki 0.30
drug3245 Standard supportive care Wiki 0.30
drug1421 Group Lifestyle Balance™ Wiki 0.30
drug2172 Negative Ion Generator Wiki 0.30
drug726 Cannabis, Medical Wiki 0.30
drug1407 Goal-Oriented Attentional Self-Regulation (GOALS) Wiki 0.30
drug3740 YinHu QingWen Decoction Wiki 0.30
drug2417 Pacing + mindfulness Wiki 0.30
drug3884 fMRI Wiki 0.30
drug1235 Exercise Testing and Training Wiki 0.30
drug539 Brain Health Education (BHE) Wiki 0.30
drug779 Chloroquine Sulfate Wiki 0.21
drug1549 Hydroxychloroquine Sulfate Regular dose Wiki 0.21
drug422 BNT162b2 Wiki 0.21
drug1548 Hydroxychloroquine Sulfate Loading Dose Wiki 0.21
drug421 BNT162b1 Wiki 0.17
drug784 Chloroquine phosphate Wiki 0.17
drug3395 Telemedicine Wiki 0.15
drug1093 Doxycycline Wiki 0.13
drug2855 Remdesivir Wiki 0.06
drug1745 Ivermectin Wiki 0.06
drug2557 Placebo oral tablet Wiki 0.05
drug1520 Hydroxychloroquine Wiki 0.03
drug2505 Placebo Wiki 0.03

Correlated MeSH Terms (34)

Name (Synonyms) Correlation
D000070642 Brain Injuries, Traumatic NIH 0.85
D001924 Brain Concussion NIH 0.30
D000070627 Chronic Traumatic Encephalopathy NIH 0.30
Name (Synonyms) Correlation
D013226 Status Epilepticus NIH 0.30
D002543 Cerebral Hemorrhage NIH 0.30
D013345 Subarachnoid Hemorrhage NIH 0.30
D005879 Tourette Syndrome NIH 0.30
D014947 Wounds and Injuries NIH 0.22
D000690 Amyotrophic Lateral Sclerosis NIH 0.21
D000755 Anemia, Sickle Cell NIH 0.21
D016472 Motor Neuron Disease NIH 0.21
D001714 Bipolar Disorder NIH 0.21
D059350 Chronic Pain NIH 0.18
D012640 Seizures NIH 0.17
D013313 Stress Disorders, Post-Traumatic NIH 0.16
D005356 Fibromyalgia NIH 0.15
D001927 Brain Diseases NIH 0.15
D006470 Hemorrhage NIH 0.15
D009461 Neurologic Manifestations NIH 0.13
D013119 Spinal Cord Injuries NIH 0.12
D059352 Musculoskeletal Pain NIH 0.12
D010300 Parkinsonian NIH 0.11
D015212 Inflammatory Bowel Diseases NIH 0.11
D040921 Stress Disorders, Traumatic NIH 0.11
D004194 Disease NIH 0.10
D003424 Crohn Disease NIH 0.10
D012598 Scoliosi NIH 0.08
D009103 Multiple Sclerosis NIH 0.08
D020521 Stroke NIH 0.08
D013577 Syndrome NIH 0.03
D003141 Communicable Diseases NIH 0.02
D007239 Infection NIH 0.02
D045169 Severe Acute Respiratory Syndrome NIH 0.01
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (12)

Name (Synonyms) Correlation
HP:0006802 Abnormal anterior horn cell morphology HPO 0.30
HP:0002133 Status epilepticus HPO 0.30
HP:0002138 Subarachnoid hemorrhage HPO 0.30
Name (Synonyms) Correlation
HP:0001342 Cerebral hemorrhage HPO 0.30
HP:0007354 Amyotrophic lateral sclerosis HPO 0.30
HP:0100754 Mania HPO 0.21
HP:0012532 Chronic pain HPO 0.20
HP:0001250 Seizure HPO 0.17
HP:0001298 Encephalopathy HPO 0.15
HP:0002037 Inflammation of the large intestine HPO 0.11
HP:0100280 Crohn's disease HPO 0.10
HP:0001297 Stroke HPO 0.08

Clinical Trials

Navigate: Correlations   HPO

There are 11 clinical trials

1 Multi-Level Assessment and Rehabilitation of Combat Mild TBI

One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with mild TBI and comorbid conditions. When completed, these studies will inform us whether training core attentional self-regulatory control functions via personally-relevant activities will be effective in improving daily life for Veterans with mild TBI and comorbid conditions. The study design will provide a test not only of potential benefits for real life functioning, but also determine to what extent these benefits are related to actual changes in cognitive/behavioral performance and brain networks corresponding to these functions. This project will provide a foundation for future studies to investigate the neural mechanisms that support improvements of cognition and behavior in mTBI.

  1. Brain Injuries,
  2. Brain Injuries, Traumatic
  1. Behavioral: Goal-Oriented Attentional Self-Regulation (GOALS)
  2. Other: Brain Health Education (BHE)
  3. Device: fMRI
MeSH:Brain Injuries Brain Injuries, Traumatic

Primary Outcomes

Description: Single Test for Attention, Executive Function and Mental Flexibility

Measure: Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition-Switching Task

Time: 6 months after enrollment
2 Neurobiological and Psychological Benefits of Exercise in Chronic Pain and PTSD

The wars in Iraq and Afghanistan are creating a new generation of Veterans, including an increasing number of women Veterans, who present with comorbid PTSD and chronic pain conditions from recent deployment-related physical injuries and exposure to psychological trauma. Health behavior change has become increasingly important in treating these conditions and proactively preventing long-term negative health sequelae, in order to benefit these Veterans directly and reduce the growing challenges to our healthcare system. The proposed CDA-2 program of research will use an innovative translational research approach to study whether a chronic progressive -based exercise program will reduce chronic pain in patients with PTSD and to elucidate and modify potential PTSD-related deficiencies in neurobiological and psychological responses to exercise to optimize the physical and psychological benefits of exercise for these individuals.

  1. Chronic Musculoskeletal Pain
  2. Posttraumatic Stress Disorder (PTSD)
  3. Mild or Moderate Traumatic Brain Injury
  1. Behavioral: Exercise Testing and Training
MeSH:Musculoskeletal Pain Brain Injuries Brain Injuries, Traumatic Chronic Pain Stress Disorders, Post-Traumatic
HPO:Chronic pain

Primary Outcomes

Description: To be administered at: Screening Evaluation & Endpoint 13 week exercise test sessions This 30-item structured interview is designed to assess both the 17 symptoms of PTSD and the 8 hypothesized associated features. The scale yields a dichotomous diagnosis of PTSD, and also provides a continuous score of frequency and severity for each symptom. In addition, a behaviorally anchored probe question is provided for each symptom to increase the reliability of administration. The CAPS-5 is currently in the process of being validated however its previous version demonstrated excellent sensitivity (.81) and specificity (.95).57

Measure: Change from Baseline: Clinician Administered PTSD Scale -5

Time: Baseline and endpoint (at 13 weeks)

Description: The WHY-MPI has been demonstrated to be applicable across a variety of clinical pain conditions. Its brevity, validity/ reliability, self-report nature and ease of scoring make it ideal for both clinical and research purposes. The WHY-MPI is sensitive to change following rehabilitation. Please note only the interference subscale of the WHY-MPI will be administered in this study.

Measure: Change from Baseline: West Haven=Yale Multidimensional Pain Inventory- Interference Subscale (WHY-MPI)

Time: Baseline, Midpoint (at 6 weeks) and Endpoint (at 13 weeks)
3 Efficacy of an Evidence-based Weight-loss Intervention Post Traumatic Brain Injury

The purpose of this RCT is to examine the efficacy of a Group Lifestyle Balance™ (GLB) program adapted for people with traumatic brain injury (TBI) on primary (weight) and secondary outcomes at 3, 6, 12, and 18 months from enrollment into the program.

  1. Traumatic Brain Injury
  1. Behavioral: Group Lifestyle Balance™
  2. Other: Attention Control Group
MeSH:Brain Injuries Brain Injuries, Traumatic Wounds and Injuries

Primary Outcomes

Description: Weight will be obtained using the same scale over the study period that is accessible to people with and without a mobility device (e.g. walker; wheelchair)

Measure: Change in weight

Time: Baseline, 3 months, 6, months, 12 months, and 18 months

Secondary Outcomes

Description: The Garmin Vivofit will be worn for the study duration to measure physical activity data.

Measure: Step Count

Time: 3 months, 6 months, 12 months, and 18 months

Description: Waist circumference will be measured at the umbilicus and mild-upper arm circumference following American College of Sports Medicine guidelines.

Measure: Waist and Arm Circumference

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

Description: Using an automatic cuff (average of three readings, patient seated) diastolic and systolic scores will be recorded.

Measure: Blood Pressure

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

Description: Fasting venous sample will be obtained for blood glucose, HDL/LDL, cholesterol, and triglyceride level.

Measure: HbA1c and Lipid Panel

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

Description: The Framingham Heart Study diabetes risk score will be calculated using predictors including age, gender, fasting glucose, body mass index, HDL cholesterol and triglyceride levels, blood pressure, and parental history. Risk score calculator and regression model are free and used in GLB weight-loss trials. Each risk predictor is assigned points ranging from. Risk factors are combined and a total score is calculated, with higher scores designating greater 8-year risk.. The age range for this score is 45 years or older, and therefore only individuals over this age will have calculated scores. Furthermore, the minimum cut-off score is 3.

Measure: Risk of Diabetes

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

Description: Satisfaction with life will be measured using the Satisfaction with Life Scale (SWLS). The SWLS is a 5-item scale designed to measure global cognitive judgements of one's life satisfaction. Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 7-strongly agree to 1-strongly disagree. Scores are added together and a total score is calculated, with higher scores signifying higher satisfaction with life and lower scores signifying lower satisfaction with life.

Measure: Satisfaction with Life

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

Description: TSH, Cortisol, IL-6, THNF, BDNF, IGF, and VEGF will be collected.

Measure: Biomarkers

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

Description: Assesses walking speed in (m/s) which is correlated to mobility in the community, capacity to perform ADLs, risk of falls, re-hospitalization, and risk of cognitive decline.

Measure: 10 Meter Walk Test (10MWT)

Time: Baseline, 3 months, 6 months, and 12 months

Description: Assesses distance walked (rolled for wheelchair users) over 6 minutes as a sub-maximal test of aerobic capacity.

Measure: 6 Minute Walk Test (6MWT)

Time: Baseline, 3 months, 6 months, and 12 months

Description: Social Support for Diet and Exercise Behaviors Scale is a 23-item survey including four subscales: support for healthy eating (5 items); support for physical activity (11 items); social undermining for healthy eating (5 items) and physical activity (2 items). Each item is rated on a scale of 1 to 5 (1 none; 5 very often), with respondents asked to rate support from family, friends, and coworkers. Higher scores represent greater support and internal consistency ranged from Cronbach's α 0.72-0.76.

Measure: Social Support assessed by the Social Support for Diet and Exercise Behaviors Scale

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

Description: The Feasibility and Usability survey includes 14 items that assesses the participant's subjective experience with the App, level of difficulty, prompting sequence, length, and understanding. Scores above 3 on the scale (1 [totally disagree] - 5 [totally agree]) indicate that the App was easy to use.

Measure: App Feasibility and Usability using the Feasibility and Usability Survey

Time: 6 months, 12 months, and 18 months

Description: NEWS assesses residents' perception of neighborhood design features, categorized into subscales related to physical activity, including residential density, land use mix (including both indices of proximity and accessibility), street connectivity, infrastructure for walking/cycling, neighborhood aesthetics, traffic and crime safety, and neighborhood satisfaction. Subscales are scored as a mean of items. Higher scores denote higher walkability.

Measure: Neighborhood Walkability assessed by the Neighborhood Environment Walkability Scale (NEWS)

Time: Baseline and 12 months

Description: Measure includes 28 items that assess health practices among people with disabilities and yields a total Health Practices score plus 4 subscales scores regarding Exercise, Nutrition, Health Practices, and Psychological Well Being. Items are rated on a 5-point scale from 0 'not at all' to 4 'completely.' Scores range from 0-28 with higher scores indicating higher exercise self-efficacy.

Measure: Self-Reported Activities of Health using the Self-Reported Activities of Health for Health Promotion Scale

Time: Baseline, 12 months, and 18 months

Description: This inventory consists of 40 life events and asks the participant to recall if any of the events happened within the previous year (e.g., death of spouse; personal illness; change in sleep). Endorsement of these events are totaled and higher scores indicate a greater amount of stressful life events. Point values for the Holmes and Rahe Stress Inventory were weighted and summed for each individual based on scoring instructions. Individuals who scored 150 points or less were categorized as low susceptibility to a health breakdown in the next two years, 151-300 points were 50% chance of health breakdown, and 301 points or more were 80% chance of health breakdown.

Measure: Stressful Life Events assessed by the Holmes and Rahe Stress Inventory

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

Description: The GLB TBI/Attention Control groups will both use this app. Usage and engagement will be collected.

Measure: App Data

Time: 6 months, 12 months, and 18 months

Description: The MOCA is a brief, 8-section assessment of various cognitive domains including executive function, memory, language, attention, concentration, orientation, and working memory in neurologic populations. Each item on the MOCA is allocated a set of points adding up to 30.

Measure: Executive Function assessed by the Montreal Cognitive Assessment

Time: Baseline, 3 months, and 12 months

Description: Self-Report Habit Index measures self-reported perceptions of habit strength for an identified behavior. The measure has high internal reliability across four studies. The measure consists of 12 items using a 7-point Likert scale ranging from "completely disagree" to "completely agree", with higher scores representing greater perception of habit strength.

Measure: Self-reported perceptions of habit strength assessed by the Self-Report Habit Index (SRHI)

Time: Baseline, 3 months, and 12 months

Description: The PHQ-8 is a brief self-report measure of major depressive disorder, derived from the PHQ-9 by removing the last question regarding suicide assessment.It is considered to be a valid measure of depression for population-based studies and clinical populations, and has been used in studies of patients with physical injury. Frequency of symptoms during the last 2 weeks is assessed on a 0 (not at all) to 3 (nearly every day) scale. A cut-off score of 10 or greater is considered diagnostic for current depression

Measure: Depression assessed using the Patient Health Questionnaire-8 item

Time: Baseline, 12 months, and 18 months

Description: Walk Score is publically available and measures walkability of any address using a patented system. Fore each address, Walk Score analyzes hundreds of walking routes to nearby amenities and awards points based on distance to each amenities. Scores are given on a scale of 0 to 100.

Measure: Walk Score

Time: Baseline and 12 months

Description: The BAST is a 47 item, theoretically grounded, validated survey of behavioral and emotional symptoms for community-based adults with TBI. This assessment is a shortened version of the validated 77-item survey, with questions related to environmental stressors and mood removed due to repetitiveness to other questions in survey packet. Responses are asked over the past two weeks using an ordinal scale from 0 "rarely" to 5 "very often." There are 6 subscales: Negative Affect, Substance Use, Executive Function, Fatigue, Impulsivity, and Maladaptive Coping. Higher scores indicate more symptoms in those domains. This measure will be used to characterize behavioral/emotional symptoms and to explore whether these are factors that influence

Measure: Behavioral Assessment

Time: Baseline and 6 months

Description: The ten items from the General Self-Efficacy Scale (GSE) are deigned to examine goal-setting, effort investment, persistence in face of barriers and recovery from setbacks as constructs of perceived self-efficacy. The total score is the sum ranging from 10-40 and the instrument has been normed against the U.S. Adult population with a mean score of 29.48.

Measure: General Self Efficacy

Time: Baseline, 12 months, and 18 months

Description: The BRFSS is a state-based system of health surveys that collects information on health risk behaviors, preventative health practices, and health care access primarily related to chronic disease and injury. The GLB-TBI uses the two subscales of Healthy Eating and Physical Activity from the 2017 version of the BRFSS. It consists of 14 items.

Measure: Behavioral Risk Factor Surveillance

Time: Baseline, 3, 6, 12, and 18 months.

Description: This is an FDA cleared and validated indirect calorimetry device. It is handheld and measures oxygen consumption (V02) to determine resting metabolic rate (RMR)

Measure: MedGem

Time: Baseline

Description: The metabolic score calculator will be used at all time points to determine the risk for metabolic syndrome. The following variables will be used to determine metabolic risk using the free metabolic risk calculator: gender, race and ethnicity, systolic blood pressure, fasting glucose, triglycerides, high-density lipoprotein (HDL), weight, height, and waist circumference. Scores are calculated are standardized to the general population.

Measure: Metabolic Score Calculator (MetS)

Time: Baseline, 3, 6, 12, and 18 months

Description: Information on substance use will be collected using the AUDIT-C (for alcohol use) and three questions regarding tobacco and non-prescriptive drug use.

Measure: Substance Use

Time: Baseline, 12 months

Description: This self-report survey was developed by the National Institute of Mental Health. The full survey consists of 64 questions with an open-ended section at the end to elicit concerns and feedback related to the effects of COVID-19. For this current study, however, only sections on Exposure Status (10 items), Life Changes (15 items), and Emotions/Worries (7 items), and the open-ended question will be asked. Questions are asked "over the past two weeks."

Measure: CRISIS (CoRonavIruS Health Impact Survey) V0.3 Adult Baseline Form

Time: Up to 12 months

Description: The Social Isolation Short-Form 4a is taken from the Patient-Reported Outcomes Measurement Information System (PROMIS). This form assesses the perceptions of being "avoided, excluded, detached, disconnected from, or unknown by, others. There is no timeframe for the form. The measure is normed to the US population.

Measure: PROMIS Social Isolation Short Form 4a

Time: Up to 12 months

Description: To assess media exposure and fear of media exposure during COVID-19 we have added 6 questions. These are asked "over the past two weeks." These questions address time spent watching the television, listening to radio, reading the newspaper, and searching the internet and social media. In addition, a 6th question related to fear is asked using a 5-point Likert scale.

Measure: Media Questionnaire

Time: Up to 12 months
4 A Sleep Intervention to Improve Rehabilitation in Veterans With Chronic mTBI

Traumatic brain injury (TBI) is a major cause of disability in the Veteran population, often resulting in chronic pain and sleep disturbances, among other issues. Extensive rehabilitative efforts are usually required and often prevent return to the workforce and community. Disturbed sleep and excessive daytime sleepiness are among the most pervasive and enduring problems after TBI, which the investigators hypothesize is a significant contributor to these functional impairments and an impediment toward rehabilitation. Thus, this research aims to enhance sleep quality as a means to reduce pain and improve quality of life and functional outcome measures in Veterans with TBI. The investigators predict that the proposed intervention, morning bright light therapy, if found effective, will be cost-effective, rapidly deployable, and highly accepted by Veterans with TBI.

  1. Traumatic Brain Injury
  1. Device: Morning Bright Light Therapy
  2. Device: Negative Ion Generator
MeSH:Brain Injuries Brain Injuries, Traumatic

Primary Outcomes

Description: NIH PROMIS Pain Scale 4 questions; each question is a 0-4 scale, total score range is 0-16 Higher scores represent worse outcomes

Measure: self-reported pain change determined via the NIH PROMIS scale

Time: Pre- and post-4 weeks of MBLT or sham treatment, and 12 weeks following the end of MBLT or sham treatment
5 RECONsolidation of Traumatic Memories to ResOLve Post Traumatic Stress Disorder (RECONTROLPTSD)

Posttraumatic Stress Disorder (PTSD) is a common cause of morbidity in combat veterans, but current treatments are often inadequate. Reconsolidation of Traumatic Memories (RTM) is a novel treatment that seeks to alter key aspects of the target memory (e.g., color, clarity, speed, distance, perspective) to make it less impactful, and reduce nightmares, flashbacks, and other features of PTSD. The memory is reviewed in the context of an imaginal movie theater, presenting a fast (~45 sec) black and white movie of the trauma memory, with further adjustment as needed so the patient can comfortably watch it. Open and waitlist studies of RTM have reported high response rates and rapid remission, setting the stage for this randomized, controlled, single-blind trial comparing RTM versus prolonged exposure (PE), the PTSD therapy with the strongest current evidence base. The investigators hypothesize that RTM will be non-inferior to PE in reducing PTSD symptom severity post-treatment and at 1-year follow up; will achieve faster remission, with fewer dropouts; will improve cognitive function; and that epigenetic markers will correlate with treatment response. The investigators will randomize 108 active or retired service members (SMs) with PTSD to ≤10 sessions of RTM or PE, affording power to test our hypotheses while allowing for ≤ 25% dropouts. The investigators will use an intent to treat analysis, and the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, or DSM5 (CAPS-5), conducted by blinded assessors, will be the primary outcome measure. Secondary measures of depression (PHQ-9), anxiety (GAD-7), sleep (PSQI), and functional status (WHOQOL-100), will be assessed pre- and post-treatment, and at 2, 6, and 12 months. ANOVA will compare symptom severity over time within and between groups. Blood draws will be obtained pre- and posttreatment to assess predictors of treatment response and epigenetic markers of change. The NIH Toolbox Neurocognitive Assessment, pre- and post-treatment, will assess impact on cognitive function. The investigators will track comorbid TBI, anticipating it will not adversely impact response. More effective therapies for PTSD, with and without TBI, must be developed and evaluated. RTM is safe and promising, but requires testing against evidence-based interventions in well-designed randomized clinical trials (RCTs). The full study can now be conducted via video conferencing due to COVID-19.

  1. Posttraumatic Stress Disorder
  2. Traumatic Brain Injury
  1. Behavioral: Reconsolidation of Traumatic Memories (RTM)
  2. Behavioral: Prolonged Exposure (PE)
MeSH:Brain Injuries Brain Injuries, Traumatic Dis Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: the gold standard for PTSD diagnosis, a trained expert administrator scores PTSD symptom severity; range 0-80, higher score represents greater severity

Measure: Clinician Administered PTSD Symptom Scale for DSM5 (CAPS-5)

Time: week 10

Secondary Outcomes

Description: well-validated and widely used 9-item self-report measure of depression symptom severity, range 0-27, higher score represents greater severity

Measure: Change in Patient Health Questionnaire (PHQ-9) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Description: a reliable 20-item screen for PTSD, in which each item is rated on a 5-point Likert scale, range 0-80, higher score represents greater severity

Measure: Change in PTSD Checklist for DSM5 (PCL5) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Description: a clinically validated 9-item assessment of sleep quality and sleep disturbances; range 0 to 21, higher score represents greater severity

Measure: Change in Pittsburgh Sleep Quality Index (PSQI) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Description: a reliable 22-item self-report measure assessing functional status and post concussive symptoms, range 0-88, higher score represents greater severity

Measure: Change in Neurobehavioral Symptom Inventory (NSI) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Description: a reliable 100 item self-report inventory measuring overall quality of life in 8 dimensions; range 100 to 500, higher score represents greater severity

Measure: Change in World Health Organization Quality of Life Inventory (WHOQOL-100) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Other Outcomes

Description: inflammatory cytokine that increases with physical and psychological trauma, measured at the picogram per milliliter level, present in plasma at detectable levels in all individuals with the single molecule array (SIMOA) technology to be applied, but expected to decrease in response to intervention

Measure: Change in plasma tumor necrosis factor-alpha level

Time: week 10, compared to baseline

Description: inflammatory cytokine that increases with physical and psychological trauma, measured at the picogram per milliliter level, present in plasma at detectable levels in all individuals with the SIMOA technology to be applied, but expected to decrease in response to intervention

Measure: Change in plasma interleukin-6 level

Time: week 10, compared to baseline

Description: inflammatory cytokine that increases with physical and psychological trauma, measured at the picogram per milliliter level, present in plasma at detectable levels in all individuals with the SIMOA technology to be applied, but expected to decrease in response to intervention

Measure: Change in plasma interleukin-10 level

Time: week 10, compared to baseline

Description: Normalized Summary Score for a battery of 7 tests to measure various aspects of cognition including memory, executive function, attention span; normed for age, with a score of 50 being average, scores greater than 50 demonstrate greater than average cognitive function, and scores lower than 50 indicating lower than average cognitive function

Measure: Change in NIH Toolbox Cognition Battery (NIH-TB) Neurocognitive Assessment Composite Score

Time: week 10, compared to baseline
6 Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

  1. Chronic Pain
  2. Chronic Pain Syndrome
  3. Chronic Pain Due to Injury
  4. Chronic Pain Due to Trauma
  5. Fibromyalgia
  6. Seizures
  7. Hepatitis C
  8. Cancer
  9. Crohn Disease
  10. HIV/AIDS
  11. Multiple Sclerosis
  12. Traumatic Brain Injury
  13. Sickle Cell Disease
  14. Post Traumatic Stress Disorder
  15. Tourette Syndrome
  16. Ulcerative Colitis
  17. Glaucoma
  18. Epilepsy
  19. Inflammatory Bowel Diseases
  20. Parkinson Disease
  21. Amyotrophic Lateral Sclerosis
  22. Chronic Traumatic Encephalopathy
  23. Anxiety
  24. Depression
  25. Insomnia
  26. Autism
  27. Opioid-use Disorder
  28. Bipolar Disorder
  29. Covid19
  30. SARS-CoV Infection
  31. COVID-19
  32. Corona Virus Infection
  33. Coronavirus
  1. Drug: Cannabis, Medical
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Fibromyalgia Crohn Disease Inflammatory Bowel Diseases Parkinson Disease Multiple Sclerosis Brain Injuries Brain Injuries, Traumatic Seizures Moto Motor Neuron Disease Amyotrophic Lateral Sclerosis Brain Diseases Tourette Syndrome Chronic Traumatic Encephalopathy Anemia, Sickle Cell Disease Syndrome Sclerosis Chronic Pain Wounds and Injuries Stress Disorders, Traumatic Bipolar Disorder Stress Disorders, Post-Traumatic
HPO:Abnormal anterior horn cell morphology Amyotrophic lateral sclerosis Bilateral tonic-clonic seizure Bipolar affective disorder Chronic pain Crohn's disease Encephalopathy Focal-onset seizure Generalized-onset seizure Inflammation of the large intestine Mania Seizure

Primary Outcomes

Description: Covid-19 infection rates in cannabis users will be compared to rates in the general population. Our online questionnaire responses will compare infection rates of cannabis users in this study against the Johns Hopkins University Coronavirus Research Center data (

Measure: Prevention of COVID-19

Time: Five years

Description: Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population. Patients will answer the widely used FLU-PRO questionnaire, which asks about flu symptoms and severity, to capture diagnoses, symptoms, and medical interventions related to COVID-19. The data from cannabis user patients will be compared with national and international data surveys, such as the Covid Symptom Study (

Measure: Treatment of COVID-19

Time: Five years

Description: The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.

Measure: Treatment of Symptoms

Time: Five years

Secondary Outcomes

Description: Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.

Measure: Cannabis Impact on Quality of Life

Time: Five years

Description: Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.

Measure: Cannabis Route and Dosing

Time: Five years

Description: Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.

Measure: Monitoring Adverse Events

Time: Five years
7 Behavioral Profile Matching: A Precision Medicine Approach to Concussion Rehabilitation

At least 1 in 5 people who sustain a concussion will have persistent symptoms and difficulties with daily activities. The researchers have identified two unhelpful coping styles following a concussion - avoidance and endurance. Individuals who engage in avoidance behavior may benefit from a different type of treatment than those who engage in endurance behavior. The researchers will evaluate whether assigning individuals to a specific psychologically-informed treatment tailored to their coping style is practical, acceptable, and beneficial for their recovery.

  1. Mild Traumatic Brain Injury
  1. Behavioral: Graded exposure therapy
  2. Behavioral: Pacing + mindfulness
MeSH:Brain Injuries Brain Injuries, Traumatic Brain Concussion

Primary Outcomes

Measure: World Health Organization Disability Assessment Schedule (WHODAS) 2.0 12-item

Time: Initial assessment, past 30 days.

Secondary Outcomes

Measure: Rivermead Postconcussion Symptom Questionnaire

Time: initial assessment, past 24 hours.
8 Exploring Brain Damages After COVID-19 Infection

Although direct evidence is currently lacking, the high identity between SARS-CoV-1 and SARS-CoV-2 suggests, that the latter viral strain could also infect the Central Nervous System (CNS). Indeed, some cases of SARS-COV2 encephalitis begin to be described and CNS damages are increasingly highlighted in the literature, but still not objectified by imaging and do not allow to explain the entire clinical patterns. We hypothesise that these CNS damages are not always objectified by Magnetic Resonance Imaging (MRI) but could be indirectly observed by a physiological dysfunction of neural conduction in the brainstem. We will explore brainstem disruption through an electrophysiological approach.

  1. SARS-CoV 2
  1. Procedure: Auditory Evoked Potentials (AEP)
  2. Procedure: Blink and Masseter Inhibitory Reflex
MeSH:Brain Injuries

Primary Outcomes

Description: Latencies of electrophysiological responses with Auditory Evoked Potentials

Measure: Latency of electrophysiological response

Time: Inclusion (T0)

Description: Delay of Muscle contraction (Blink reflex)

Measure: Delay of Muscle contraction

Time: Inclusion (T0)

Description: Delay of silent period while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)

Measure: Delay of silent period

Time: Inclusion (T0)

Description: Duration of silent period while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)

Measure: Duration of silent period

Time: Inclusion (T0)

Description: Inhibition rate while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)

Measure: Inhibition rate

Time: Inclusion (T0)
9 COVID-19 and Disability: The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries

Document and evaluate the impact of societal restrictions due to the pandemic on SCI- and ABI-related disability and functional impairments, and the resultant effects on psychological wellbeing, physical wellbeing and quality of life for those with SCI/ABI.

  1. Brain Injuries
  2. Stroke
  3. Spinal Cord Injuries
MeSH:Brain Injuries Spinal Cord Injuries Wounds and Injuries

Primary Outcomes

Description: Fear of COVID-19 Questionnaire

Measure: Change in Fear of COVID-19

Time: baseline, 3 months, 6 months

Secondary Outcomes

Description: NeuroQol SF v1.0 - Ability to Part. in SRA

Measure: Change in ability to participate in social roles and activities

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Depression

Measure: Change in depressive symptoms

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Pos. Affect & Well-Being

Measure: Change in positive affect and well-being

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Anxiety

Measure: Change in anxiety

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Fatigue

Measure: Change in fatigue

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Emotional & Beh. Dyscontrol

Measure: Change in emotional and behavioural dyscontrol

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Satisfaction w SRA

Measure: Change in satisfaction with social roles and activities

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Sleep Disturbance

Measure: Change in sleep disturbance

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Stigma

Measure: Change in stigma

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Cognitive Function

Measure: Change in cognitive function

Time: baseline, 3 months, 6 months

Description: 23 questions about strategies to social distance

Measure: Change in social distancing strategies used

Time: baseline, 3 months, 6 months

Description: 22 questions about social distancing

Measure: Change in thoughts and feelings about social distancing

Time: baseline, 3 months, 6 months
10 Severe Neurologic Injury Outcomes During COVID-19 Crisis

A prospective cohort minimal risk study to determine the impact of the COVID-19 crisis on outcomes of neurologically injured ICU patients.

  1. Sars-CoV2
  2. Severe Neurologic Injury
  3. Ischemic Stroke
  4. Hemorrhagic Stroke
  5. Intracerebral Hemorrhage
  6. Subarachnoid Hemorrhage
  7. Traumatic Brain Injury
  8. Status Epilepticus
MeSH:Stroke Brain Injuries Brain Injuries, Traumatic Subarachnoid Hemorrhage Cerebral Hemorrhage Status Epilepticus Hemorrhage Wounds and Injuries
HPO:Cerebral hemorrhage Status epilepticus Stroke Subarachnoid hemorrhage

Primary Outcomes

Measure: In-hospital Mortality

Time: At hospital discharge, approximately 1 month

Measure: 30-day mortality

Time: 30 days post-hospital discharge

Secondary Outcomes

Description: Care treatment such as ventilator use, intubation, and/or tracheostomy

Measure: Limitations of patient care- Frequency of care not being provided

Time: During In-hospital course, up to 1 month

Measure: Limitations of patient care- Conversion of DNR/DNI/CMO status

Time: During In-hospital course, up to 1 month
11 Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients

Viral pandemics, such as HIV and SARS-Cov-V1, have shown that they can lead to acute and / or delayed neurological complications. At the actual context of the pandemic Coronavirus disease 2019 (COVID-19), neurological manifestations seem to be confirmed since in 85% of COVID-19 patients, present neurological symptoms, including anosmia, ageusia, periorbital pain, dizziness, fatigue, even moderate headache, moderate memory and/or behavioral disorders. However, these neurological manifestations are not well studied and their radiological features are not well described. It is therefore important to assess these potential neurological complications in COVID-19 patients. To the investigator knowledge, there is no previous study in the literature describing spectral brain changes in COVID + patients. Thus, the goal of this work is to describe the radiological semiology using MRI and particularly Magnetic Resonance Spectroscopic (MRS) biomarkers in the evaluation of acute and / or delayed brain damage in COVID + patients presenting a neurological manifestations that are initially related to the cranial nerves damage.

  1. Covid19
  2. Neurological Manifestations
  3. Brain Damage
  1. Other: Magnetic Resonance Spectroscopy (MRS).
MeSH:Brain Injuries Neurologic Manifestations

Primary Outcomes

Description: The radiological semiology as described by MRI and particularly Magnetic Resonance Spectroscopic (MRS) biomarkers in the COVID-19 patients presenting neurological manifestations related initially to the cranial nerves damage.

Measure: Variation from baseline of MRI radiological semiology in COVID-19 patients

Time: 9 months after patient inclusion

HPO Nodes


Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials

HPO Nodes


Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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