Repetitive Transcranial Magnetic Stimulation (rTMS) to Promote Hand Recovery in Stroke
rTMS
rTMS and Motor Learning Training to Promote Recovery From Hemiparesis
2 other identifiers
interventional
40
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 stroke
Started Sep 2007
Longer than P75 for phase_1 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 2, 2009
CompletedFirst Posted
Study publicly available on registry
June 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedAugust 31, 2011
August 1, 2011
3.9 years
June 2, 2009
August 30, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
box and block finger prehension test
45 days
Secondary Outcomes (2)
cortical excitability
from pretest to posttest (2 weeks)
cognitive function
pretest to posttest (2 weeks)
Study Arms (4)
rTMS only
EXPERIMENTALbrain stimulation to non-stroke primary motor area
Finger tracking training
EXPERIMENTALMotor learning training using finger flexion/extension tracking movements toward a target.
rTMS and finger tracking
EXPERIMENTALCombination of rTMS and tracking
Sham
PLACEBO COMPARATORSham rTMS treatment
Interventions
600 pulses of 6 hz priming rTMS at 90% of threshold followed by 600 pulses of low-frequency rTMS at 90% of threshold.
one hour of repeated finger tracking movements toward a changing target.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- No history of seizures, no medical devices or metal incompatible with fMRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James R Carey, PhD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2009
First Posted
June 4, 2009
Study Start
September 1, 2007
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
August 31, 2011
Record last verified: 2011-08