Contralesional Inhibitory rTMS for Recovery of Arm Function After Stroke

NCT04205526 | Unknown

• 1 other identifier: MP-05-2020-1891
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The CanStim consensus working group (multidisciplinary team of experts in rTMS from institutions across Canada) developed consensus recommendations for a protocol to deliver rTMS as an adjunct to physiotherapy to improve arm function in a Pan-Canadian stroke rehabilitation clinical trial. The overall goal of this multi-center feasibility trial is not to demonstrate that rTMS is effective, but to demonstrate that each site can recruit the assigned number of patients within a certain period, perform the stimulation procedure in conjunction with the protocol-specified physiotherapy intervention, complete the therapy protocol and enter complete datasets for each patient into the CanStim database. A secondary aim is to identify potential weaknesses of the consensus protocol that may need to be modified before performing a larger scale trial testing for the efficacy of the intervention.

Conditions

Feasibility Study

Outcome Measures

Primary Outcomes (3)

• Change in the Fugl-Meyer Upper Arm Assessment between baseline, Post Day 1 and Post Day 30

  Index to assess sensorimotor impairment in stroke.

  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.

• Change in the Action Research Arm Test between baseline, Post Day 1 and Post Day 30

  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.

  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.

• Change in the Modified Rankin Scale between baseline, Post Day 1 and Post Day 30

  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.

  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.

Secondary Outcomes (1)

• Change in the Canadian Occupational Performance Measure between baseline, Post Day 1 and Post Day 30

  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.

Study Arms (2)

Active rTMS

EXPERIMENTAL

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.

Device: Active rTMS

Sham control

SHAM COMPARATOR

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.

Device: Sham TMS

Interventions

Active rTMS DEVICE

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.

Active rTMS

Sham TMS DEVICE

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.

Sham control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Thiel, Alexander, M.D.: lead
• Ottawa Heart Institute Research Corporation: collaborator

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Study Officials

• ALEXANDER THIEL, MD, Phd

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon L Shapiro, BScN

CONTACT

5143408222; sshapiro@jgh.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The only individual that will be unblinded is the person administering the rTMS.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist, Researcher

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 19, 2019
• Study Start: January 1, 2021
• Primary Completion: April 1, 2024
• Study Completion: June 30, 2024
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)