Enhancing the Response to Rehabilitation After Stroke Using Repetitive Transcranial Magnetic Stimulation (rTMS)

This study has been terminated.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Lisa Koski, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00850408
First received: February 24, 2009
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

Weakness of the arm and hand results in long-term disability for many persons who suffer a stroke. After the initial recovery phase, only limited gains are achieved by retraining the weak limb to perform daily tasks. However, new treatment strategies such as repetitive transcranial magnetic stimulation (rTMS) show promise for enhancing motor recovery after stroke. rTMS is a noninvasive technique for modifying brain activity that aims to improve motor function by correcting abnormal patterns that occur after stroke. We believe that giving rTMS right before a therapy session will prepare the brain so that the patient is better able to participate in and benefit from training of the hand and arm. The goal of this study is to test how well this new strategy works to improve recovery in people who have mild to moderate weakness of the arm and hand after stroke.

Participants will receive magnetic stimulation of the movement area of the brain just prior to arm and hand training for a series of eight sessions. We will evaluate changes in hand and arm function after the intervention and one month later to see if the changes are maintained. We will also test whether some groups of people benefit more than others from the intervention. If improvements in hand and arm function are observed after the intervention, we will test it more rigourously in a future clinical trial in which participants are randomly assigned to different treatment conditions. This research will show whether brain stimulation can be used to improve the effectiveness of rehabilitation care.


Condition Intervention Phase
Stroke
Procedure: Repetitive Transcranial Magnetic Stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing the Response to Rehabilitative Interventions After Stroke Using Transcranial Magnetic Stimulation

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • The Box and Blocks Test of Manual Dexterity [ Time Frame: Post-intervention and 1 month later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cortical excitability of the motor system [ Time Frame: Post-intervention and one month later ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: June 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Real rTMS
Real rTMS - subjects receiving real repetitive TMS - 1Hz over unaffected hemisphere
Procedure: Repetitive Transcranial Magnetic Stimulation
For real rTMS,1200 pulses will be delivered at a frequency of 1Hz, with an intensity equal to the 115% of the motor threshold as established at baseline. For Sham rTMS, procedures will be identical to those used for real rTMS with the exception that a placebo coil will be used, which provides acoustic and sensory stimulation like the real coil but does not stimulate neural tissue. 20-minute Real and Sham stimulation sessions will be administered bi-weekly for a period of 4 weeks
Sham Comparator: Sham rTMS
Sham rTMS
Procedure: Repetitive Transcranial Magnetic Stimulation
For real rTMS,1200 pulses will be delivered at a frequency of 1Hz, with an intensity equal to the 115% of the motor threshold as established at baseline. For Sham rTMS, procedures will be identical to those used for real rTMS with the exception that a placebo coil will be used, which provides acoustic and sensory stimulation like the real coil but does not stimulate neural tissue. 20-minute Real and Sham stimulation sessions will be administered bi-weekly for a period of 4 weeks

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • first clinical stroke involving the middle cerebral artery confirmed by CT or MRI scan during acute care at the MUHC, or second stroke involving the same hemisphere when there were no clinical residual effects from the first stroke;
  • cortical or subcortical stroke resulting in hemiparesis;
  • at least 3 months post-stroke;
  • discharged from standard rehabilitation;
  • able to provide informed consent, to follow instructions and participate in therapy, as evidenced by Mini Mental State Exam score > 14;
  • able to understand instructions in English or French.

Exclusion Criteria:

  • minimal or no residual upper extremity motor impairment;
  • severe upper extremity motor impairment as indicated by inability to produce any voluntary contraction of intrinsic hand muscles; severe cognitive impairment in language or attention sufficient to impair communication during the consenting or intervention procedures (score < 14 on the Mini Mental Status Exam);
  • other central nervous system disorder or peripheral neuropathy of the upper extremity;
  • pain, spasticity, or other complications that would prevent participation in the intervention;
  • history of seizure confirmed by interview and medical chart review;
  • comorbidity such as Parkinson's disease, osteoarthritis, or cancer, precluding full participation in the assessments and in the experimental intervention;
  • other conditions that increase the risk of side effects due to rTMS procedures: metal in cranium, intracardiac line, increased intracranial pressure, pregnancy, cardiac pacemaker, medication pump, tricyclic antidepressants, neuroleptics, history of seizure in the immediate family
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850408

Locations
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University Health Center
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Lisa M Koski, PhD McGill University
  More Information

No publications provided

Responsible Party: Lisa Koski, PhD, McGill University Health Center
ClinicalTrials.gov Identifier: NCT00850408     History of Changes
Other Study ID Numbers: 172502, CHIR MOP 84354, CHIR MOP 84354
Study First Received: February 24, 2009
Last Updated: April 22, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
Stroke
rTMS
TMS
Rehabilitation
Upper Extremity

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 July 24, 2014