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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00913211
First received: June 2, 2009
Last updated: August 30, 2011
Last verified: August 2011
  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

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • box and block finger prehension test [ Time Frame: 45 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00913211

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014