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NCT00913211 · ClinicalTrials.gov registry record · Phase 1
Repetitive Transcranial Magnetic Stimulation (rTMS) to Promote Hand Recovery in Stroke
A Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00913211 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 40 participants.
The verdict
NCT00913211, a Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
Paralysis following stroke stems not only from the loss of neurons killed by the stroke but also from the loss of neurons lying dormant in the stroke hemisphere. One of the reasons viable neurons become dormant (down-regulated) is because of excessive interhemispheric inhibition imposed on them from the nonstroke hemisphere. The challenge in neurorehabilitation is to restore excitability and voluntary control of these down-regulated neurons in the stroke hemisphere. Suppression of the source of this excessive interhemispheric inhibition can be achieved with the noninvasive method called repetitive transcranial magnetic stimulation (rTMS). It has been shown in healthy subjects that the known depressant effects of low-frequency rTMS can be increased and prolonged by preceding it with 6-Hz priming stimulation. In a recent safety study, we showed that one treatment of 6-Hz primed low-frequency rTMS applied to the nonstroke hemisphere is safe. It is now important to evaluate a series of these treatments and whether their efficacy can be enhanced by combining the rTMS with motor learning training. The specific aims of this study are to determine the efficacy, mechanism, and safety of a series of 5 treatments of 6-Hz primed low-frequency rTMS applied to nonstroke hemisphere and combined with motor learning training to promote recovery of the paretic hand. Forty subjects with stroke will be randomly assigned to one of four treatment groups. The rTMS/only group will receive 20 min. of rTMS per day. The Track/only group will receive 20 min. of finger tracking training per day. The rTMS/combined group will receive alternating days of the rTMS and Track treatments. The rTMS/sham group will receive 20 min. of rTMS using a sham electrode each day. The hypotheses are: 1) the rTMS/combined group will show the greatest improvements in hand function, 2) the rTMS/combined group will show the greatest improvements in cortical excitability using paired-pulse TMS testing and in brain reo
Interventions
- DEVICE Sham rTMS
- DEVICE rTMS
- PROCEDURE Motor learning training
- PROCEDURE rTMS and Tracking
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2007-09 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00913211
The ClinicalTrials.gov registry entry for NCT00913211 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Sham rTMS is the first listed.
NCT00913211 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00913211 about?
NCT00913211 is a clinical study titled "Repetitive Transcranial Magnetic Stimulation (rTMS) to Promote Hand Recovery in Stroke". Paralysis following stroke stems not only from the loss of neurons killed by the stroke but also from the loss of neurons lying dormant in the stroke hemisphere. One of the reasons viable neurons become dormant (down-regulated) is because of excessive interhemispheric inhibition imposed on them from...
What is the current status of trial NCT00913211?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2007-09. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00913211?
The interventions under investigation include: Sham rTMS (DEVICE), rTMS (DEVICE), Motor learning training (PROCEDURE), rTMS and Tracking (PROCEDURE).
Who is sponsoring clinical trial NCT00913211?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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