Research: Contralesional inhibitory rTMS for Recovery of Arm function after stroke – a feasibility trial

Description:

ConTRA-stoke is a randomized controlled outcome adjudication blinded feasibility trial to test the implementation feasibility  of a 15 day treatment course of inhibitory rTMS in combination with task specific upper extremity therapy in subacitre stroke patients. The goal is 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.

Sites Involved:

• McGill University (Coordinating Centre), Montreal, Quebec
• University of Calgary, Calgary, Alberta
• University of British Columbia, Vancouver, British Columbia
• Université Laval, Quebec City, Quebec
• Memorial University of Newfoundland, St. John’s, Newfoundland and Labrador
• Université de Montréal, Quebec
• University of Ottawa, Ontario
• Western University, London, Ontario

CanStim Principal Investigators:

Dr. Alexander Thiel, MD, McGill University
Dr. Jodi Edwards, PhD, University of Ottawa
Dr. Numa Dancause, PhD, Université de Montreal

CanStim Site  Investigators:

Dr. Sean Dukelow, MD, PhD. University of Calgary 
Dr. Lara Boyd, PT, PhD. University of BC
Dr. Catherine Mercier erg., PhD. Université Laval
Dr. Michelle Ploughman, PhD. Memorial University of Newfoundland
Dr. Dorothy Barthelemy, PhD. Université de Montréal
Dr. Sue Peters, PhD. Western University
Dr. Marc Roig, PhD. McGill, University, Quebec

Research Aim:

• Recruit a total of 49 patients across participating sites, randomizing patients to treatment (rTMS) or sham arm of the trial
• To complete a 15-day treatment course using rTMS combined with the Graded Repetitive Arm Supplementary Program (GRASP) as the paired upper extremity therapy for the primary outcome of change in the Fugl-Meyer Upper Arm Assessment between baseline, post-intervention Day 1 and post-intervention Day 30.

Target Population:

Individuals at the sub-acute phase of stroke recovery (2 weeks – 3 months) who are experiencing upper extremity motor impairment.

Recruitment:

The trial is actively recruiting patients. Recruitment and data collection is currently ongoing.

Eligibility:

Inclusion Criteria: 

• Stroke patients between 2 weeks and 3 months of stroke onset
• Both cortical and subcortical stroke
• Between 18 and 90 years
• English or French as language of daily use
• Must be able to participate in a standard of care upper extremity therapy program

Exclusion Criteria:

• Prior symptomatic ischemic or hemorrhagic stroke
• Severe comprehension deficit that may compromise informed consent
• 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
• Auditory or visual deficits that cannot be corrected and might impair testing

Outcome Measures:

• Primary:  Modified Rankin, Fugl-Meyer (upper extremity), Action Reach Arm Test (ARAT)
• Secondary: Canadian Occupational Performance Measure (COPM)

Rehabilitation Intervention (rTMS):

• Participants to receive either real rTMS or Sham rTMS
• 1Hz frequency (inhibitory) rTMS over contralesional M1 can modulate mechanisms of transcallosal inhibition, promoting functional reorganization in affected regions in the ipsilesional hemisphere
• Suprathreshold (120% RMT) once daily (1800 pulses over 30 min) for 15 sessions
• MRI-guided stereotaxic neuronavigation to identify M1

Rehabilitation Intervention (Physiotherapy):

• • Usual care replaced by specific upper limb therapy (GRASP)
  • 60 minutes of Graded Repetitive Arm Supplementary Program (GRASP) to be given immediately after rTMS, followed by additional 30 minutes of therapist guided therapy as deemed necessary by treating therapist for 15 days
  • Patients, therapists and research personnel performing the clinical outcome assessments will be blinded, only the TMS technician will be unblinded