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NCT03826030 · ClinicalTrials.gov registry record · Phase 2
Transcranial Direct Current Stimulation for Post-stroke Motor Recovery
A Phase 2 study of Stroke, Ischemic and Motor Activity, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
- 14
- Study locations
NCT03826030: Completed Phase 2 study of Stroke, Ischemic and Motor Activity, sponsored by Duke University.
NCT03826030 is a Phase 2 study of Stroke, Ischemic and Motor Activity that has completed, run by Duke University. The registered enrollment target is 129 participants, below the 286-participant average among 33 other Stroke, Ischemic trials with a reported enrollment target (55% lower). The trial reports 14 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03826030, a Phase 2 study of Stroke, Ischemic and Motor Activity, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
- 14
- Study locations
Study Summary
This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct currents to stimulate specific parts of the brain affected by stroke. The adjunctive rehabilitation therapy is called "modified Constraint-Induced Movement Therapy" (mCIMT). During this therapy the subject will wear a mitt on the hand of the arm that was not affected by a stroke and force to use the weak arm. The study will test 3 different doses of brain stimulation in combination with mCIMT to find out the most promising one.
Primary Outcome
The Fugl-Meyer Upper-Extremity (FM-UE) is a measure of motor impairment (0 to 66 points, with higher points indicating less impairment). FM-UE scale consists of a 33-item assessment which provides a global assessment of UE motor impairment. A rater provides an ordinal rating (2=near normal ability/response, 1=partial ability, 0=unable to perform/no response). The FM-UE scale is a proven scale with excellent intra-rater reliability (0.99), inter-rater reliability (0.99), test-retest reliability (
Conditions Studied
Interventions
- DEVICE Sham
- DEVICE Low dose tDCS
- DEVICE High dose tDCS
- BEHAVIORAL mCIMT
Study Locations (14)
Ohio
- University of Cincinnati Medical Center - Cincinnati
- Cleveland VA Medical Center - Cleveland
Pennsylvania
- Moss Rehabilitation Research Institute - Elkins Park
- University of Pittsburgh Medical Center Presbyterian Hospital - Pittsburgh
Alabama
- University of Alabama at Birmingham Hospital - Birmingham
California
- Keck Hospital of USC - Los Angeles
District of Columbia
- MedStar National Rehabilitation Hospital - Washington D.C.
Georgia
- Emory Rehabilitation Hospital - Atlanta
Kentucky
- Cardinal Hill Rehabilitation Hospital - Lexington
Massachusetts
- Baystate Medical Center - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2019-09-01 |
| Est. Completion | 2024-09-19 |
| Phase | Phase 2 |
What the finished NCT03826030 record still lists
NCT03826030 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 286-participant average among 33 other Stroke, Ischemic trials with a reported enrollment target (55% lower).
The record links to 3 conditions, with Stroke, Ischemic appearing as the primary indexed condition, and to 4 interventions - of which Sham is the first listed.
NCT03826030 lists 14 locations in 12 states (Ohio, Pennsylvania, Alabama).
Frequently Asked Questions
What is clinical trial NCT03826030 about?
NCT03826030 is a clinical study titled "Transcranial Direct Current Stimulation for Post-stroke Motor Recovery". This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct currents to stimulate spec...
What is the current status of trial NCT03826030?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2019-09-01. Estimated completion is 2024-09-19.
What conditions does trial NCT03826030 study?
This clinical trial studies the following conditions: Stroke, Ischemic, Motor Activity, Upper Extremity Paralysis.
What interventions are being tested in trial NCT03826030?
The interventions under investigation include: Sham (DEVICE), Low dose tDCS (DEVICE), High dose tDCS (DEVICE), mCIMT (BEHAVIORAL).
Who is sponsoring clinical trial NCT03826030?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03826030 being conducted?
This trial has 14 study locations across Alabama, California, District of Columbia, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03826030's enrollment target sits among peer trials
129 11th of 33 higher than 23 of 33 other Stroke, Ischemic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke, Ischemic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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