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NCT03208036 · ClinicalTrials.gov registry record · NA
Restoration of Cognitive Function With TDCS and Training in Serious Mental Illness
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 22
- Enrollment target
NCT03208036: Completed NA study, sponsored by VA Office of Research and Development.
NCT03208036 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 22 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03208036, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
Study Summary
Development of interventions that can effectively target and remediate the cognitive and functional impairment associated with serious mental illness 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 test the hypotheses that cognitive remediation paired with tDCS will be more efficacious than cognitive remediation delivered with sham stimulation and that intervention-induced cognitive change will be sustainable. To examine the incremental benefit of pairing tDCS with cognitive remediation, clinically stable outpatients between the ages of 18-65 who have a diagnosis of schizophrenia, schizoaffective disorder, or bipolar 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 45-minute bridging group focus on application of cognitive skills in everyday life. To assess intervention-induced change, work
Interventions
- DEVICE Sham Stimulation
- BEHAVIORAL Cognitive Remediation
- DEVICE TDCS
- BEHAVIORAL Bridging Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-07-15 |
| Est. Completion | 2022-02-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03208036
The ClinicalTrials.gov registry entry for NCT03208036 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Sham Stimulation is the first listed.
NCT03208036 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03208036 about?
NCT03208036 is a clinical study titled "Restoration of Cognitive Function With TDCS and Training in Serious Mental Illness". Development of interventions that can effectively target and remediate the cognitive and functional impairment associated with serious mental illness is a treatment priority. Transcranial direct current stimulation (tDCS) is a safe, non-invasive neuromodulation technique that is capable of stimulati...
What is the current status of trial NCT03208036?
This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2018-07-15. Estimated completion is 2022-02-28.
What interventions are being tested in trial NCT03208036?
The interventions under investigation include: Sham Stimulation (DEVICE), Cognitive Remediation (BEHAVIORAL), TDCS (DEVICE), Bridging Group (BEHAVIORAL).
Who is sponsoring clinical trial NCT03208036?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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