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rTMS for Stroke Recovery (ConTRAstroke Trial)

N/A
Recruiting
Led By ALEXANDER THIEL, MD, Phd
Research Sponsored by Thiel, Alexander, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18 and 90 years
Patients with both cortical and subcortical stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

ConTRAstroke Trial Summary

This trial is designed to test whether or not rTMS can be delivered effectively as part of stroke rehabilitation in multiple centers across Canada.

Who is the study for?
This trial is for stroke patients aged 18-90, within 2 weeks to 3 months of their stroke. They must speak English or French, be able to join standard upper extremity therapy, and have a certain level of arm function they can potentially regain. Excluded are those with severe comprehension issues, epilepsy, life-threatening diseases, neurodegenerative/psychiatric conditions, uncorrectable sensory deficits affecting testing, previous strokes or contraindications to MRI/TMS.Check my eligibility
What is being tested?
The trial tests the feasibility of using rTMS (repetitive Transcranial Magnetic Stimulation) alongside physiotherapy to improve arm function after a stroke. It's not about proving effectiveness but ensuring sites can recruit patients timely, follow the stimulation protocol with physiotherapy correctly and report data into the CanStim database.See study design
What are the potential side effects?
While this trial focuses on feasibility rather than side effects directly, rTMS may cause discomfort at the stimulation site or headaches in some individuals. The sham TMS should have no active side effects as it's designed to mimic rTMS without delivering actual stimulation.

ConTRAstroke Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 90 years old.
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I have had a stroke affecting both the surface and deeper parts of my brain.
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I can perform the GRASP test.

ConTRAstroke Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the Action Research Arm Test between baseline, Post Day 1 and Post Day 30
Change in the Fugl-Meyer Upper Arm Assessment between baseline, Post Day 1 and Post Day 30
Change in the Modified Rankin Scale between baseline, Post Day 1 and Post Day 30
Secondary outcome measures
Change in the Canadian Occupational Performance Measure between baseline, Post Day 1 and Post Day 30

Side effects data

From 2022 Phase 2 trial • 72 Patients • NCT03144232
27%
Headache
16%
Fatigue
3%
Eye twitch
3%
Jaw Pain
3%
Site discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham rTMS

ConTRAstroke Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active rTMSExperimental Treatment1 Intervention
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.
Group II: Sham controlPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active rTMS
2019
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationOTHER
189 Previous Clinical Trials
92,272 Total Patients Enrolled
Thiel, Alexander, M.D.Lead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
ALEXANDER THIEL, MD, PhdPrincipal InvestigatorJewish General Hospital

Media Library

Active rTMS Clinical Trial Eligibility Overview. Trial Name: NCT04205526 — N/A
Feasibility Studies Research Study Groups: Active rTMS, Sham control
Feasibility Studies Clinical Trial 2023: Active rTMS Highlights & Side Effects. Trial Name: NCT04205526 — N/A
Active rTMS 2023 Treatment Timeline for Medical Study. Trial Name: NCT04205526 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research still recruiting volunteers?

"Clincialtrials.gov reveals that this experiment is actively searching for participants, having first been uploaded on January 1st 2021 and last edited on June 17th 2022."

Answered by AI

Am I eligible to be a participant in this research project?

"This medical trial is aiming to recruit up to 49 eligible participants who have undergone feasibility studies and are between 18-90 years of age."

Answered by AI

Does this experiment permit the participation of individuals aged 45 and above?

"To be eligible to join this clinical trial, the patient must between 18 and 90 years of age."

Answered by AI

How many volunteers are partaking in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical trial was initially added on January 1st 2021 and has recently been updated on June 17th 2022. The protocol is looking for approximately 49 participants from a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Contralesional Inhibitory rTMS for Recovery of Arm Function After Stroke
Dr. Alexander Thiel 2021. "Contralesional Inhibitory rTMS for Recovery of Arm Function After Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04205526.
~11 spots leftby May 2025
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