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

Primary Purpose

Stroke

Status

Terminated

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Repetitive Transcranial Magnetic Stimulation

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, rTMS, TMS, Rehabilitation, Upper Extremity

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Royal Victoria Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real rTMS

Sham rTMS

Arm Description

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

Sham rTMS

Outcomes

Primary Outcome Measures

The Box and Blocks Test of Manual Dexterity

Secondary Outcome Measures

Cortical excitability of the motor system

Full Information

NCT ID

NCT00850408

First Posted

February 24, 2009

Last Updated

April 22, 2013

Sponsor

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

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT00850408

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Terminated

Study Start Date

June 2008 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke, rTMS, TMS, Rehabilitation, Upper Extremity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Real rTMS

Arm Type

Experimental

Arm Description

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

Arm Title

Sham rTMS

Arm Type

Sham Comparator

Arm Description

Sham rTMS

Intervention Type

Procedure

Intervention Name(s)

Repetitive Transcranial Magnetic Stimulation

Intervention Description

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

Primary Outcome Measure Information:

Title

The Box and Blocks Test of Manual Dexterity

Time Frame

Post-intervention and 1 month later

Secondary Outcome Measure Information:

Title

Cortical excitability of the motor system

Time Frame

Post-intervention and one month later

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisa M Koski, PhD

Organizational Affiliation

McGill University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal Victoria Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

24363954

Citation

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.

Results Reference

derived

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

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