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Clinical Trial Summary

The long-term goal of this project is to develop upper limb rehabilitation interventions that can be utilized for stroke survivors, specifically survivors with more severe limitations in use of their affected upper limb.

This study will utilize a novel method of non-invasive brain stimulation in conjunction with upper limb training given for 15 visits over a period of 5 weeks.

The study will include the following site visits:

- Eligibility Screening and Informed Consent Visit

- An MRI visit

- Two testing visits in which motor function of the upper limb and neurophysiology will be measured

- Fifteen intervention visits during which patients will receive upper limb training in conjunction with non-invasive brain stimulation

- Repeat testing of motor function of the upper limb and neurophysiology

- Repeat MRI testing

- A follow-up visit completed 3 months after the completion of interventions

Clinical Trial Description

In a pilot, randomized controlled study, 24 stroke patients with moderate/severe impairments will receive non-invasive brain stimulation (repetitive Transcranial Magnetic Stimulation or rTMS) to one of two targets in the brain in conjunction with upper limb training for 3 days a week for 5 weeks. The primary outcome will be upper limb motor impairment, and secondary outcomes will be tests of functional abilities, proximal reaching performance and patient-reported disability. Associated neural mechanisms will also be studied using neurophysiological and functional connectivity MRI techniques. Damage to ipsilesional corticospinal pathways will be indexed with diffusion tensor imaging (DTI). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03868410
Study type Interventional
Source The Cleveland Clinic
Contact Kyle J. O'Laughlin, MS
Phone 216-445-6728
Status Recruiting
Phase Early Phase 1
Start date April 1, 2019
Completion date September 30, 2021

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