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

NCT ID: NCT00850408

Last Updated: 2013-04-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2011-03-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Real rTMS

Real rTMS - subjects receiving real repetitive TMS - 1Hz over unaffected hemisphere

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation

Intervention Type: PROCEDURE

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 rTMS

Sham rTMS

Group Type: SHAM_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Lisa Koski

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa M Koski, PhD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

Royal Victoria Hospital

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 24363954 (View on PubMed)

Other Identifiers

CHIR MOP 84354

Identifier Type: -

Identifier Source: secondary_id

CHIR MOP 84354

Identifier Type: OTHER

Identifier Source: secondary_id

172502

Identifier Type: -

Identifier Source: org_study_id