Name (Synonyms) | Correlation | |
---|---|---|
drug1754 | Pacing + mindfulness Wiki | 0.45 |
drug1055 | High Intensity Interval Training group Wiki | 0.45 |
drug1581 | Negative Ion Generator Wiki | 0.45 |
drug2341 | Standard therapy for COVID-19 according to the stablished hospital protocols. Wiki | 0.45 |
drug1004 | Goal-Oriented Attentional Self-Regulation (GOALS) Wiki | 0.45 |
drug393 | Brain Health Education (BHE) Wiki | 0.45 |
drug617 | Community based combination HIV prevention package Wiki | 0.45 |
drug1006 | Graded exposure therapy Wiki | 0.45 |
drug1916 | Prolonged Exposure (PE) Wiki | 0.45 |
drug2711 | Yoga group Wiki | 0.45 |
drug97 | AVP-786 Wiki | 0.45 |
drug615 | Communication type Wiki | 0.45 |
drug2050 | Reconsolidation of Traumatic Memories (RTM) Wiki | 0.45 |
drug2816 | fMRI Wiki | 0.45 |
drug611 | Combination Wiki | 0.45 |
drug1520 | Morning Bright Light Therapy Wiki | 0.45 |
drug2031 | Ravulizumab Wiki | 0.32 |
drug603 | Colchicine Tablets Wiki | 0.26 |
drug315 | Baricitinib Wiki | 0.17 |
drug2326 | Standard of care Wiki | 0.10 |
drug1822 | Placebo Wiki | 0.03 |
Name (Synonyms) | Correlation | |
---|---|---|
D001930 | Brain Injuries, NIH | 0.85 |
D001924 | Brain Concussion NIH | 0.45 |
D011595 | Psychomotor Agitation NIH | 0.45 |
D000374 | Aggression NIH | 0.45 |
D040921 | Stress Disorders, Traumatic NIH | 0.10 |
D013313 | Stress Disorders, Post-Traumatic NIH | 0.09 |
D004194 | Disease NIH | 0.08 |
There are 5 clinical trials
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.
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 enrollmentThis is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in participants with traumatic brain injury (TBI).
Description: The NPI-C can be used to rate the presence of neuropsychiatric symptoms across 14 domains. The scores for each item within an individual domain/subscale range from 0 to 3, with a higher score indicating increased severity. The NPI-C-3 is comprised of the aggression, agitation, and irritability/lability subscales. The scores for the three subscales are summed to create the total NPI-C-3 composite score, which ranges from 0 to 99, with a higher score indicating increased severity.
Measure: Change from Baseline to Week 12 in the Composite of the Clinical Impression Severity Scores on the Neuropsychiatric Inventory Clinician Rating Scale (NPI-C) Subscales of Aggression, Agitation, and Irritability/Lability (NPI-C-3) Time: Baseline; Week 12Description: The mCGI-C will be used to assess the clinician's general impression of the participant's treatment response. The mCGI-C is a 7-point (1 to 7) modified version of the CGI-C scale. A higher score represents worsening of symptoms.
Measure: Change from Baseline to Week 12 in Modified Clinical Global Impression of Change (mCGI-C) Raw Scores Time: Baseline; Week 12Description: The NPI-C is used to rate the presence of neuropsychiatric symptoms across 14 domains. The scores for each item within an individual domain/subscale range from 0 to 3, with a higher score indicating increased severity.
Measure: Change from Baseline to Week 12 in NPI-C Rating Scale Subscales Scores for Aggression, Agitation, Irritability/Lability, and Disinhibition Time: Baseline; Week 12Description: The mCGI-S will be used to assess the clinician's view of the participant's severity of aggression, agitation, and irritability symptoms. The mCGI-S is a 7-point (1 to 7) modified version of the CGI-S scale. In all cases, a higher score represents increased severity.
Measure: Change from Baseline to Week 12 in Modified Clinical Global Impression of Severity (mCGI-S) Scale Scores Time: Baseline; Week 12Description: The PGI-S is a single-question scale that specifically assesses the severity of symptoms of neurobehavioral disinhibition, including aggression, agitation, and irritability, on a 7-point scale : 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Measure: Change from Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) Scores Time: Baseline; Week 12Description: The PGI-C is a 7-point (1 to 7) scale used to assess the participant's assessment of treatment response. A higher score indicates worsening of the symptoms.
Measure: Change from Baseline to Week 12 in Patient Global Impression of Change (PGI-C) Raw Scores Time: Baseline; Week 12Traumatic 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.
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 treatmentPosttraumatic 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.
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 10Description: 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 baselineDescription: 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 baselineDescription: 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 baselineDescription: 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 baselineDescription: 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 baselineDescription: 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 baselineDescription: 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 baselineDescription: 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 baselineDescription: 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 baselineAt 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.