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Repetitive Transcranial Magnetic Stimulation (rTMS) to Promote Hand Recovery in Stroke (rTMS)

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ClinicalTrials.gov Identifier: NCT00913211
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : August 31, 2011
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Stroke Device: rTMS Procedure: Motor learning training Procedure: rTMS and Tracking Device: Sham rTMS Phase 1

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: rTMS and Motor Learning Training to Promote Recovery From Hemiparesis
Study Start Date : September 2007
Primary Completion Date : August 2011
Study Completion Date : August 2011
Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. box and block finger prehension test [ Time Frame: 45 days ]

Secondary Outcome Measures :
  1. cortical excitability [ Time Frame: from pretest to posttest (2 weeks) ]
    Paired pulse TMS testing will show increase in the ratio of paired pulse to single pulse MEP amplitude when stimulating ipsilesional M1.

  2. cognitive function [ Time Frame: pretest to posttest (2 weeks) ]
    There will be no decline in function on the Hopkins Verbal learning test.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913211

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: James R Carey, PhD University of Minnesota - Clinical and Translational Science Institute
More Information

Additional Information:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00913211     History of Changes
Other Study ID Numbers: 0704M06701
1R01HD053153-01A2 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: August 31, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases