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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3351 | TDCS Wiki | 0.58 |
| drug1234 | Exercise Intervention Wiki | 0.58 |
| drug398 | BI 425809 Wiki | 0.58 |
Navigate: Correlations HPO
There are 3 clinical trials
Development of interventions that can effectively target and remediate the cognitive and functional impairment associated with schizophrenia is a treatment priority. Transcranial direct current stimulation (tDCS) is a safe, non-invasive neuromodulation technique that is capable of stimulating brain activity to facilitate learning. The primary objective of this study is to evaluate the pairing of two therapeutic techniques, cognitive remediation and tDCS, as a cognitively enhancing intervention. This study is designed to address four questions. Is cognitive remediation paired with tDCS more efficacious than cognitive remediation delivered with sham stimulation? Is it possible to predict responsiveness to the intervention? Is intervention-induced cognitive change sustainable? Are there barriers to implementing this intervention in clinical practice? To examine the incremental benefit of pairing tDCS with cognitive remediation, a 110 clinically stable outpatients between the ages of 18-60 who have a diagnosis of schizophrenia or schizoaffective disorder will be enrolled in a double-blind, double-baseline, sham-controlled clinical trial. Participants will be randomized in a 1:1 ratio to receive either tDCS or sham stimulation concurrent with working memory focused cognitive remediation. Training will be offered to participants in a small group format. Training will consist of 48 sessions, with 2-3 sessions scheduled in a week. Each training session will last 2 hours. One hour will be spent completing cognitive exercises that require working memory skills on a computer. TDCS or sham stimulation will be offered concurrent with the first 20 minutes of training with a StarStim neuromodulator. One mA of anodal stimulation will be applied to the left dorsal lateral prefrontal cortex and the cathodal electrode will be placed in the contralateral supraorbital position. Upon completion of working memory training, participants will transition to a 30-minute discussion group. The discussion will focus on application of cognitive skills in everyday life. Effective strategies for approaching cognitive tasks will be described and practiced. Participant experience with aspects of the training will be monitored with self-report measures of motivation, mood, and physical reactions. To assess intervention-induced change, working memory, other aspects of cognition, functional capacity, and community functioning will be assessed pre- and post-intervention. Cognitive outcomes will be assessed with training tasks as well as tasks that are unfamiliar to participants. A performance-based measure will be used to assess functional capacity for everyday living skills and a self-report instrument will be used to assess community functioning. Potential confounds such as symptom severity, medication changes, outside treatment hours, and significant life stressors will be assessed individually every 2 weeks during the intervention phase of the study. Sustainability of intervention-induced change will be assessed with assessment sessions 6 weeks and 6 months post-intervention. Change in performance during the first 12 training sessions on two working memory training tasks, a n-back task and a complex span task, will be used to determine if early response to treatment is predictive of post-intervention outcomes. An intent-to-treat analysis will be used to analyze intervention-induced change. Regression analyses will be conducted to identify predictors of treatment response. Achieving the proposed objectives will yield important information about the efficacy, durability, and efficiency of a novel pairing of cognitively enhancing interventions. Findings will inform treatment development for patients with schizophrenia as well for patients with other cognitively compromising illnesses.
Description: Working Memory Domain Age and Gender Corrected T-Scores on MATRICS Consensus Cognitive Battery
Measure: Working Memory Capacity Composite Score Time: Change from Baseline Working Memory Capacity at 4 monthsDescription: Average of MATRICS Consensus Cognitive Battery Attention Domain Age and Gender Corrected T-score and performance measured with d prime on the Dot Pattern Expectancy Task
Measure: Goal Maintenance Composite Score Time: Change from Baseline Goal Maintenance at 4 monthsDescription: Average of sensitivity measures on the Sternberg Item Recognition Paradigm and the Suppress Task
Measure: Interference Control Composite Score Time: Change from Baseline Interference Control at 4 monthsDescription: T-score
Measure: The University of California San Diego Performance-Based Skills Assessment Time: Change from Baseline T-score on Adaptive Skills test at 4 monthsDescription: Total score
Measure: First-Episode Social Functioning Scale Time: Change from Baseline Social Functioning at 4 monthsDescription: D-prime on N-back task
Measure: N-Back Performance Time: Change from Baseline N-back performance at 4 monthsDescription: Total Score
Measure: Complex Span Task Time: Change from Baseline Complex Span Task performance at 4 monthsThe primary objective of this Phase II exploratory trial is to provide Proof of Concept (PoC) data to assess the effect on cognition of oral once daily administration of BI 425809 given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment and adjunctive Computerized Cognitive Training (CCT).
Description: Schizophrenia Cognition Rating Scale (SCoRS)
Measure: Change from baseline in the effect of cognitive deficit on day-to-day functioning as measured by SCoRS total score Time: Up to 12 weeksDescription: Positive and Negative Syndrome Scale (PANSS)
Measure: Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score Time: Up to 12 weeksPurpose: To test the effectiveness of an exercise intervention that combines group walking, activity tracking, and heart rate monitoring (i.e. Physical Activity can Enhance Life, PACE-Life) on the physical and mental health for individuals with schizophrenia spectrum disorder. Participants: 56 individuals with schizophrenia spectrum disorders. Procedures (methods): During the baseline assessment, all participants will be provided with a Fitbit wristband and instructed how to use it. During the first group session, participants will be taught how to use their heart rate (on the Fitbit) to determine how fast participants should walk (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to determine the appropriate heart from the watch, which will be used to guide the intensity of the walk will be provided to participants and reviewed at each group session. Participants randomly assigned to PACE Life clinic based group sessions will arrive at the STEP clinic to meet the entire group and leaders and be reminded of the heart rate (HR) that corresponds with the intensity of that group session. Next, the group will go outside and walk for 30 minutes. At the completion of 30 minutes, everyone will go back into the clinic for water and review of the walk. After the second group session of each week, participants will receive weekly progress reports of their steps and minutes spent walking the prior week (obtained from Fitbit devices). During this session, participants will also set individual goals for the upcoming week for both their "intensity walks" and total steps per day. Participants randomly assigned to Fitbit Alone will be given a Fitbit and shown how to use it by study staff. Participants will also be given information on current recommended physical activity guidelines (150 min/week of moderate intensity exercise) and will be told that study staff may be contacting them on a weekly basis (or shorter, if necessary) if it looks like participants are not wearing their Fitbit for a certain number of days (e.g. 3 consecutive days) or to troubleshoot any issues. If necessary, participants might be invited to come to the clinic to get assistance on any Fitibit or exercise related issues.
Description: The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).
Measure: Difference in Participant's Total Distance During 6-minute Walk Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in overall minutes spent walking per week from baseline to last study visit (up to 20 minutes). This information will be obtained from the participant's Fitbit. Higher scores reflect more minutes walking.
Measure: Mean Difference in Minutes Spent Walking Time: Baseline and the last study visit (up to 20 weeks)Description: Mean difference in daily steps from baseline to last study visit (up to 20 weeks). This information will be obtained from the participants Fitbit. Higher scores reflect more daily steps.
Measure: Mean Difference in Daily Steps Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in overall score from baseline to last study visit (up to 20 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness).
Measure: Mean Difference Overall UCLA Loneliness Scale Score Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in the overall score from baseline to last study visit (up to 20 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis).
Measure: Mean Difference Overall PANSS Score Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in body weight change from baseline to last study visit (up to 20 weeks). Expected normal BMI ranges from 14 to 54. Higher scores reflect worse outcomes (i.e. greater body mass).
Measure: Mean Difference in Body Weight Change Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in blood pressure change from baseline to last study visit (up to 20 weeks).
Measure: Mean difference in blood pressure change Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in resting heart rate change from baseline to last study visit (up to 20 weeks). Expected normal heart rate ranges from 40 to 120. Higher scores reflect worse outcomes (poorer heart condition).
Measure: Mean Difference in Resting Heart Rate Change Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in composite motivation score from baseline to last study visit (up to 20 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. 0 corresponds to "not true for me" and 4 corresponds to "very true for me." Possible scores range from 0 to 46. Higher scores reflect better outcomes (higher autonomous motivation to exercise).
Measure: Mean Difference in Composite Motivation Score on the Behavioral Regulation Exercise Questionnaire (BREQ-2) Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNE is an 11 item self-report scale. Answers are on a 5 point Likert scale ranging from "I don't agree at all" to "I completely agree." Possible scores range from 11 to 55. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise).
Measure: Mean Difference in Composite Score on the Basic Psychological Needs in Exercise Scale (BPNES) Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). 2. The PACES is an 18 item self-report scale. Answers are on a 7-point scale. Possible scores range from 18 to 126. Higher scores reflect better outcomes (greater enjoyment of physical activity).
Measure: Mean Difference in Composite Score on the Physical Activity Enjoyment Scale (PACES) Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNS is a 21 item self-report scale. Answer are on a 7-point Likert scale ranging from "not at all true" to "very true." Possible scores range from 21 to 147. Higher scores reflect better outcomes (better autonomy, competence, and relatedness).
Measure: Mean Difference in Composite Score on the Basic Psychological Needs Scale (BPNS) Time: Baseline and the last study visit (Up to 20 weeks)Description: Mean difference in composite score from mid-treatment to last study visit (up to 20 weeks). The Autonomy Scale is a 6 item self-report scale. Answers are made using a 7-point scale. Possible scores range from 7 to 46. Higher scores reflect better outcomes (better relationship between research participant and staff.
Measure: Mean Difference in Composite Score on the Autonomy Support Scale Time: Baseline and the last study visit (Up to 20 weeks)Description: Total score at Post treatment visit only (16 weeks). The End of Study survey measures participant's satisfaction and feedback with the PACE-Life trial. The survey is a 18 item self-report scale, consisting of both Likert scale and open-ended items. Answers are made using a 5-point Likert scale. Possible scores range from 18-90. Higher scores reflect higher levels of satisfaction and enjoyment in the study.
Measure: End of Study Survey Time: Post treatment only (16 weeks)Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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.
Drug Reports MeSH Reports HPO Reports