CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Sham StimulationWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug2424 TDCS Wiki 1.00

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D012559 Schizophrenia NIH 0.58

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0100753 Schizophrenia HPO 0.58

There is one clinical trial.

Clinical Trials


1 Restoration of Cognitive Function With TDCS and Training in Schizophrenia

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.

NCT03208036 Schizophrenia Device: TDCS Device: Sham Stimulation
MeSH:Schizophrenia
HPO:Schizophrenia

Primary Outcomes

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 months

Description: 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 months

Description: 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 months

Description: 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 months

Secondary Outcomes

Description: Total score

Measure: First-Episode Social Functioning Scale

Time: Change from Baseline Social Functioning at 4 months

Description: D-prime on N-back task

Measure: N-Back Performance

Time: Change from Baseline N-back performance at 4 months

Description: Total Score

Measure: Complex Span Task

Time: Change from Baseline Complex Span Task performance at 4 months


Related HPO nodes (Using clinical trials)