Clinical trial NCT04205526: Contralesional Inhibitory rTMS for Recovery of Arm Function After Stroke
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Feasibility Study
Lead sponsor: Thiel, Alexander, M.D.
Sponsor class: INDIV
Collaborators: name: Ottawa Heart Institute Research Corporation
First posted: 2019-12-19
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Rehabilitation is critical for reducing stroke-related disability. Although intensive physiotherapy improves function after a stroke, the frequency and intensity of therapy in a standard clinical rehabilitation session is insufficient to invoke these changes. Transcranial magnetic stimulation (TMS) is a safe, non-invasive method of stimulating the human brain. Repetitive TMS (rTMS) may have the potential to enhance the brain's ability to re-learn specific functions and reduce the amount of standard therapy required to achieve certain functional gains after stroke. Although two recent multicenter studies have begun to test the benefits of applying rTMS during stroke rehabilitation, large scale clinical trials demonstrating the efficacy of rTMS for post-stroke functional motor recovery are lacking. The use of rTMS interventions in stroke rehabilitation trials has been limited by a lack of consensus regarding the optimal protocol for the clinical application of TMS in stroke populations. The Canadian Platform for Trials in Non-Invasive Brain Stimulation (CanStim) is a national platform that aims to facilitate multicenter clinical trials for non-invasive brain stimulation interventions to augment recovery from stroke. As a first step, CanStim investigators convened a multidisciplinary team of experts in rTMS from institutions across Canada to form the CanStim Consensus Working Group and develop consensus recommendations for a protocol to deliver rTMS as an adjunct to standard therapy in a national stroke rehabilitation clinical trial.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Fugl-Meyer Upper Arm Assessment between baseline, Post Day 1 and Post Day 30
timeFrame: 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.
measure: Change in the Action Research Arm Test between baseline, Post Day 1 and Post Day 30
timeFrame: 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.
measure: Change in the Modified Rankin Scale between baseline, Post Day 1 and Post Day 30
timeFrame: 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:
measure: Change in the Canadian Occupational Performance Measure between baseline, Post Day 1 and Post Day 30
timeFrame: 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.
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: ALEXANDER THIEL, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: