A Novel Approach for Brain Stimulation in Severe Stroke

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

April 1, 2019

Primary Completion Date

April 21, 2023

Study Completion Date

July 13, 2023

Conditions
Stroke
Interventions
DEVICE

New Repetitive Magnetic Stimulation (rTMS) Approach

Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.

DEVICE

Conventional Repetitive Magnetic Stimulation (rTMS) Approach

Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.

Trial Locations (1)

44195

Lerner Research Institute; Cleveland Clinic Foundation, Cleveland

All Listed Sponsors
collaborator

American Heart Association

OTHER

lead

The Cleveland Clinic

OTHER

NCT03868410 - A Novel Approach for Brain Stimulation in Severe Stroke | Biotech Hunter | Biotech Hunter