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NCT03651700 · ClinicalTrials.gov registry record · Phase 2
Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Chronic Aphasia
A Phase 2 study of Aphasia, sponsored by H. Branch Coslett.
- Completed
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
- 1
- Study location
NCT03651700: Completed Phase 2 study of Aphasia, sponsored by H. Branch Coslett.
NCT03651700 is a Phase 2 study of Aphasia that has completed, run by H. Branch Coslett. The registered enrollment target is 86 participants, roughly in line with the 81-participant average among 42 other Aphasia trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03651700, a Phase 2 study of Aphasia, has completed, sponsored by H. Branch Coslett.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
- 1
- Study location
Study Summary
Transcranial Magnetic Stimulation (TMS) has been demonstrated to improve language function in subjects with chronic aphasia in a number of small studies, many of which did not include a control group. Although the treatment appears promising, data to date do not permit an adequate assessment of the utility of the technique. The investigators propose to study the effects of TMS combined with Constraint Induced Language Therapy (CILT) in 75 subjects with chronic aphasia. Subjects will be randomized in a 2:1 ratio to TMS with CILT or sham TMS with CILT. One Hz TMS at 90% motor threshold will be delivered to the right inferior frontal gyrus for 20 minutes in 10 sessions over 2 weeks; language therapy will be provided for one hour immediately after the conclusion of each session of TMS. Change from baseline in the Western Aphasia Battery Aphasia Quotient at 6 months after the end of TMS treatment will serve as the primary outcome measure.
Primary Outcome
The primary outcome measure will be the change in score on the Western Aphasia Battery Aphasia Quotient (WAB-AQ), a score assessing overall aphasia recovery. Scores can range from 0-100, with higher scores representing better outcomes. 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild. A score of 93 or higher is considered recovered.
Conditions Studied
Interventions
- DEVICE Sham TMS
- DEVICE Active TMS
- BEHAVIORAL CILT
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2019-03-28 |
| Est. Completion | 2024-08-31 |
| Phase | Phase 2 |
What the finished NCT03651700 record still lists
NCT03651700 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, roughly in line with the 81-participant average among 42 other Aphasia trials with a reported enrollment target.
The record links to 1 condition, with Aphasia appearing as the primary indexed condition, and to 3 interventions - of which Sham TMS is the first listed.
NCT03651700 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03651700 about?
NCT03651700 is a clinical study titled "Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Chronic Aphasia". Transcranial Magnetic Stimulation (TMS) has been demonstrated to improve language function in subjects with chronic aphasia in a number of small studies, many of which did not include a control group. Although the treatment appears promising, data to date do not permit an adequate assessment of the ...
What is the current status of trial NCT03651700?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2019-03-28. Estimated completion is 2024-08-31.
What conditions does trial NCT03651700 study?
This clinical trial studies the following conditions: Aphasia.
What interventions are being tested in trial NCT03651700?
The interventions under investigation include: Sham TMS (DEVICE), Active TMS (DEVICE), CILT (BEHAVIORAL).
Who is sponsoring clinical trial NCT03651700?
This trial is sponsored by H. Branch Coslett, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03651700 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03651700's enrollment target sits among peer trials
86 17th of 42 higher than 26 of 42 other Aphasia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aphasia 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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