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Contralesional Inhibitory rTMS for Recovery of Arm Function After Stroke

NCT04205526 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2022-06-23

No results posted yet for this 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.

Conditions

  • Feasibility Study

Interventions

DEVICE

Active rTMS

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.

DEVICE

Sham TMS

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.

Sponsors & Collaborators

  • Ottawa Heart Institute Research Corporation

    collaborator OTHER

  • Thiel, Alexander, M.D.

    lead INDIV

Principal Investigators

  • ALEXANDER THIEL, MD, Phd · Jewish General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2024-04-01
Completion
2024-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04205526 on ClinicalTrials.gov