An interventional study of Active rTMS and Sham TMS in Feasibility Study, Post-Stroke Patients With Upper Extremity Motor Deficit and Post-Stroke Patients With Cognitive Deficits, sponsored by Thiel, Alexander, M.D.. Completed at 1 site in Canada. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Thiel, Alexander, M.D. · Not applicable, Interventional, and Other
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 a standard behavioral intervention to improve functional outcomes after stroke in a national 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 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. A tertiary goal is to examine sex differences in neurophysiological recovery (motor evoked potential and arm functional movement recovery) after 15 treatment sessions of repetitive transcranial magnetic stimulation (rTMS) and to identify sex and gender-related factors that predict the post-stroke recovery.
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.
Thiel, Alexander, M.D. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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
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.
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.
Change in the Fugl-Meyer Upper Arm Assessment between baseline, Post Day 1 and Post Day 30
Index to assess sensorimotor impairment in stroke.
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.
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.
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.
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.
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.
Change in the Canadian Occupational Performance Measure between baseline, Post Day 1 and Post Day 30
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.
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.
Sex and Gender Questionnaire
In alignment with the feasibility endpoint for the ConTRAstroke trial, the sex and gender sub-study is the feasibility of obtaining sex and gender measures across sites and the descriptive values of both blood-based biomarkers by sex and gender identity scores (as measured by the assessment tool).
Time frame: 2 years
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Plan to share: No
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Thiel, Alexander, M.D.