Repetitive Transcranial Magnetic Stimulation (rTMS) to Promote Hand Recovery in Stroke
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Purpose
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 reorganization using fMRI, and 3) the rTMS treatment will be safe. The proposed research is important because it addresses the greatest cause of long-term disability in society, hemiparesis following stroke, and it is innovative because it applies a technique never used before, 6-Hz primed low-frequency rTMS combined with motor learning training. The potential impact of this research is a radical change to rehabilitation that accomplishes a higher quality of life in stroke.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Device: rTMS Procedure: Motor learning training Procedure: rTMS and Tracking Device: Sham rTMS |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | rTMS and Motor Learning Training to Promote Recovery From Hemiparesis |
- box and block finger prehension test [ Time Frame: 45 days ] [ Designated as safety issue: No ]
- cortical excitability [ Time Frame: from pretest to posttest (2 weeks) ] [ Designated as safety issue: No ]Paired pulse TMS testing will show increase in the ratio of paired pulse to single pulse MEP amplitude when stimulating ipsilesional M1.
- cognitive function [ Time Frame: pretest to posttest (2 weeks) ] [ Designated as safety issue: Yes ]There will be no decline in function on the Hopkins Verbal learning test.
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2007 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: rTMS only
brain stimulation to non-stroke primary motor area
|
Device: rTMS
600 pulses of 6 hz priming rTMS at 90% of threshold followed by 600 pulses of low-frequency rTMS at 90% of threshold.
|
|
Experimental: Finger tracking training
Motor learning training using finger flexion/extension tracking movements toward a target.
|
Procedure: Motor learning training
one hour of repeated finger tracking movements toward a changing target.
|
|
Experimental: rTMS and finger tracking
Combination of rTMS and tracking
|
Procedure: rTMS and Tracking
Combination of rTMS and finger tracking
|
|
Placebo Comparator: Sham
Sham rTMS treatment
|
Device: Sham rTMS
Sham treatment of rTMS
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 21 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ischemic stroke at least 6 months prior, partial movement of paretic hand, ability to follow directions, ability to walk 100 feet, motor evoked response in stroke hemisphere during TMS
Exclusion Criteria:
- No history of seizures, no medical devices or metal incompatible with fMRI
Contacts and Locations| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Principal Investigator: | James R Carey, PhD | University of Minnesota - Clinical and Translational Science Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00913211 History of Changes |
| Other Study ID Numbers: | 0704M06701, 1R01HD053153-01A2 |
| Study First Received: | June 2, 2009 |
| Last Updated: | August 30, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 19, 2013