Contralesional Inhibitory rTMS for Recovery of Arm Function After Stroke

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04205526

MP-05-2020-1891

Ages 18-90
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Stroke patients between 2 weeks and 3 months of stroke onset, patientswith both cortical and subcortical stroke, age between 18 and 90 years, English or Frenchas language of daily use, patients must be able to participate in a standard of care upperextremity therapy program and must be able to perform the GRASP AND should have a minimumdeficit that they can improve (e.g., <= 56 on FM UE).

Exclusion

Exclusion Criteria: Prior symptomatic ischemic or hemorrhagic stroke, severe comprehensiondeficit that may compromise informed consent or understanding of instructions,contraindications to MRI and/or TMS, neurodegenerative or psychiatric disease, epilepsy orEEG-documented epileptic discharges, chronic renal or liver failure, life-threateningdiseases limiting life expectancy to less than 6 months and auditory or visual deficitsthat cannot be corrected and might impair testing.

Study Design

January 01, 2021

June 30, 2024

Study 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.

Connect with a study center

Jewish General Hospital
Montreal, Quebec H3T 1E2
Canada
Active - Recruiting

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