Enhancing the Response to Rehabilitation After Stroke Using Repetitive Transcranial Magnetic Stimulation (rTMS)
2 other identifiers
interventional
11
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 stroke
Started Jun 2008
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
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 24, 2009
CompletedFirst Posted
Study publicly available on registry
February 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedApril 24, 2013
April 1, 2013
2.7 years
February 24, 2009
April 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Box and Blocks Test of Manual Dexterity
Post-intervention and 1 month later
Secondary Outcomes (1)
Cortical excitability of the motor system
Post-intervention and one month later
Study Arms (2)
Real rTMS
EXPERIMENTALReal rTMS - subjects receiving real repetitive TMS - 1Hz over unaffected hemisphere
Sham rTMS
SHAM COMPARATORSham rTMS
Interventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Related Publications (1)
Higgins J, Koski L, Xie H. Combining rTMS and Task-Oriented Training in the Rehabilitation of the Arm after Stroke: A Pilot Randomized Controlled Trial. Stroke Res Treat. 2013;2013:539146. doi: 10.1155/2013/539146. Epub 2013 Dec 3.
PMID: 24363954DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa M Koski, PhD
McGill University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
February 24, 2009
First Posted
February 25, 2009
Study Start
June 1, 2008
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
April 24, 2013
Record last verified: 2013-04