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

Stroke Clinical Trial

Official title:

Enhancing the Response to Rehabilitative Interventions After Stroke Using Transcranial Magnetic Stimulation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00850408
• Other study ID #: 172502
• Secondary ID: CHIR MOP 84354CH
• Status: Terminated
• Phase: Phase 2
• First received: February 24, 2009
• Last updated: April 22, 2013
• Start date: June 2008
• Est. completion date: March 2011

Study information

• Verified date: April 2013
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Center	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Box and Blocks Test of Manual Dexterity		Post-intervention and 1 month later	No
Secondary	Cortical excitability of the motor system		Post-intervention and one month later	No