A Novel Approach for Brain Stimulation in Severe Stroke

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT03868410
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • New Repetitive Magnetic Stimulation (rTMS) Approach — DEVICE
    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.
  • Conventional Repetitive Magnetic Stimulation (rTMS) Approach — DEVICE
    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.

Study Details

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 12 visits over a period of 6 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 * 12 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

Key Dates

Start date
Apr 1, 2019
Status verified
May 2025
Primary completion
Apr 21, 2023
Completion
Jul 13, 2023

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Contralesional dorsal premotor cortex (cPMD) rTMS + Training
    New Approach
  • Active Comparator: Ipsilesional Primary Motor Cortex (iM1) rTMS + Training
    Conventional Approach

Primary Outcome Measure

Change in Upper Extremity Fugyl-Meyer Score (UEFM) [ Time Frame: Change between Baseline and Post-Test (average 6 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lerner Research Institute; Cleveland Clinic FoundationClevelandOhio44195-

Find similar trials in Cleveland, OH

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Lerner Research Institute; Cleveland Clinic Foundation· Cleveland, OH

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