- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04205526
Contralesional Inhibitory rTMS for Recovery of Arm Function After Stroke (ConTRAstroke)
Canadian Platform for Trials With Non-Invasive Brain Stimulation: Contralesional Inhibitory rTMS for Recovery of Arm Function After Stroke - A Feasibility Trial (Canstim: ConTRA-Stroke-F)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sharon L Shapiro, BScN
- Phone Number: 22094 5143408222
- Email: sshapiro@jgh.mcgill.ca
Study Locations
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-
Quebec
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Montreal, Quebec, Canada, H3T 1E2
- Recruiting
- Jewish General Hospital
-
Contact:
- Sharon L Shapiro, BScN
- Phone Number: 22094 5143408222
- Email: sshapiro@jgh.mcgill.ca
-
Principal Investigator:
- Alexander Thiel, M.D.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Stroke patients between 2 weeks and 3 months of stroke onset, patients with both cortical and subcortical stroke, age between 18 and 90 years, English or French as language of daily use, patients must be able to participate in a standard of care upper extremity therapy program and must be able to perform the GRASP AND should have a minimum deficit that they can improve (e.g., <= 56 on FM UE).
Exclusion Criteria: Prior symptomatic ischemic or hemorrhagic stroke, severe comprehension deficit that may compromise informed consent or understanding of instructions, contraindications to MRI and/or TMS, neurodegenerative or psychiatric disease, epilepsy or EEG-documented epileptic discharges, chronic renal or liver failure, life-threatening diseases limiting life expectancy to less than 6 months and auditory or visual deficits that cannot be corrected and might impair testing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active rTMS
Sub-acute stroke patients will be randomized to receive actual rTMS treatment.
1Hz rTMS will be applied over contralesional M1 at an intensity of 120% resting motor threshold once daily for 30 minutes (approximately 1800 pulses) for a total of 15 sessions.
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Patients randomized to receive actual rTMS treatment will receive 1Hz rTMS applied over contralesional M1 at an intensity of 120% resting motor threshold once daily for 30 minutes (approximately 1800 pulses) for a total of 15 sessions.
|
Sham Comparator: Sham control
Sub-acute stroke patients randomized to receive sham rTMS.
For sham-stimulation, the TMS coil will be placed over the inter-hemispheric fissure at the vertex and stimulation will be performed with low intensity (10% resting motor threshold).
This will cause similar skin sensations as real stimulation but will not induce currents in motor relevant areas.
|
For sham-stimulation, the TMS coil will be placed over the inter-hemispheric fissure at the vertex and stimulation will be performed with low intensity (10% resting motor threshold).
This will cause similar skin sensations as real stimulation but will not induce currents in motor relevant areas.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Fugl-Meyer Upper Arm Assessment between baseline, Post Day 1 and Post Day 30
Time Frame: Baseline Testing done within the first three days then at 1 and 30 days post treatment. The Fugl Meyer has a minimum score of 0 and maximum score of 66. The higher the score the better the outcome.
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Index to assess sensorimotor impairment in stroke.
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Baseline Testing done within the first three days then at 1 and 30 days post treatment. The Fugl Meyer has a minimum score of 0 and maximum score of 66. The higher the score the better the outcome.
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Change in the Action Research Arm Test between baseline, Post Day 1 and Post Day 30
Time Frame: Baseline Testing done within the first three days then at 1 and 30 days post treatment. The test is scored from 0-57. The higher the score the better the outcome.
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An evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia.
It can assess a patients ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation.
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Baseline Testing done within the first three days then at 1 and 30 days post treatment. The test is scored from 0-57. The higher the score the better the outcome.
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Change in the Modified Rankin Scale between baseline, Post Day 1 and Post Day 30
Time Frame: Baseline Testing done within the first three days then at 1 and 30 days post treatment. The scale is between 0-6. Zero being no symptoms to 6 the patient is dead. The lower the score the better the outcome.
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It is a scale for measuring the degree of disability or dependence in the activites of daily living in individuals who have suffered a stroke.
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Baseline Testing done within the first three days then at 1 and 30 days post treatment. The scale is between 0-6. Zero being no symptoms to 6 the patient is dead. The lower the score the better the outcome.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Canadian Occupational Performance Measure between baseline, Post Day 1 and Post Day 30
Time Frame: Baseline Testing done within the first three days then at 1 and 30 days post treatment. Two scores are obtained from each participant, one for performance and one for satisfaction. Each are scored between 0-10. The higher the value the better.
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This measure serves to identify issues of personal importance to the client and to detect changes in a client's self-perception of occupational performance over time.
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Baseline Testing done within the first three days then at 1 and 30 days post treatment. Two scores are obtained from each participant, one for performance and one for satisfaction. Each are scored between 0-10. The higher the value the better.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: ALEXANDER THIEL, MD, Phd, Jewish General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MP-05-2020-1891
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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