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NCT04672044 · ClinicalTrials.gov registry record · Phase 1
TMS and Exercise for Post-stroke Pain
A Phase 1 study of Chronic Post-stroke Headache, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT04672044: Completed Phase 1 study of Chronic Post-stroke Headache, sponsored by VA Office of Research and Development.
NCT04672044 is a Phase 1 study of Chronic Post-stroke Headache that has completed, run by VA Office of Research and Development. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04672044, a Phase 1 study of Chronic Post-stroke Headache, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
There are over 7 million people living with stroke in the United States. Per year, approximately 17,000 Veterans are admitted to the VA for acute stroke. Chronic pain after stroke can occur between 10-50% of stroke survivors. Post-stroke pain (PSP) can lead to further complications in a stroke survivor's recovery. Exercise has improved PSP and associated symptoms such as mobility, fatigue, and quality of life. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive technique using electromagnetic induction for cortical neurostimulation. The use of rTMS has been explored shown to be effective in treating chronic PSP but is limited in effect duration. Our proposal will test the hypothesis that rTMS is feasible and safe to be paired with exercise. Additionally, the investigators believe a complementary effect can develop to enhance the neurostimulation duration of rTMS.
Primary Outcome
The modified Ranking scale (mRS) is a single-item, global, Likert-type scale ranging from 0-6 (higher scores mean a worse outcome) to categorize level of functional independence with comparison to pre-stroke function, accounting for activities of daily living. Participants were scored at baseline and 30 days after last intervention.
Conditions Studied
Interventions
- DEVICE Active rTMS and exercise
- COMBINATION_PRODUCT Sham rTMS+Exercise
Study Locations (1)
Alabama
- Birmingham VA Medical Center, Birmingham, AL - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2022-01-14 |
| Est. Completion | 2024-12-30 |
| Phase | Phase 1 |
What the finished NCT04672044 record still lists
NCT04672044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Chronic Post-stroke Headache appearing as the primary indexed condition, and to 2 interventions - of which Active rTMS and exercise is the first listed.
NCT04672044 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT04672044 about?
NCT04672044 is a clinical study titled "TMS and Exercise for Post-stroke Pain". There are over 7 million people living with stroke in the United States. Per year, approximately 17,000 Veterans are admitted to the VA for acute stroke. Chronic pain after stroke can occur between 10-50% of stroke survivors. Post-stroke pain (PSP) can lead to further complications in a stroke survi...
What is the current status of trial NCT04672044?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2022-01-14. Estimated completion is 2024-12-30.
What conditions does trial NCT04672044 study?
This clinical trial studies the following conditions: Chronic Post-stroke Headache.
What interventions are being tested in trial NCT04672044?
The interventions under investigation include: Active rTMS and exercise (DEVICE), Sham rTMS+Exercise (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04672044?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04672044 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04672044's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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