Customized Cortical Stimulation Therapy in the Rehabilitation of Stroke Patients

Recruiting

Phase N/A Results N/A

Trial Description

The purpose of this study is to identify and establish how the area of the brain that controls motor function (motor cortex) might serve as a new focus for treatment for stroke. The therapeutic intervention aims to identify protocols that improve motor performance after stroke.

Conditions

Interventions

  • Single-pulse Transcranial Magnetic Stimulation (TMS) Device
    Intervention Desc: Single-pulse Transcranial Magnetic Stimulation (TMS) is a brief magnetic pulse that is applied through an air-cooled coil to the section of the head that overlays the motor cortex of the brain. Subjects will be comfortably seated in a dental chair surrounded by a frame that carries a coil holder to assist with the application of TMS to the brain. Single-pulse transcranial magnetic stimulation (TMS) will be administered at 1 month visit and 6 month visit.
    ARM 1: Kind: Experimental
    Label: Stroke Patients
    Description: Subjects will undergo single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
    ARM 2: Kind: Experimental
    Label: Healthy Controls
    Description: Subjects will undergo single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months.
  • Paired-pulse Transcranial Magnetic Stimulation (ppTMS) Device
    Intervention Desc: Paired-pulse Transcranial Magnetic Stimulation (ppTMS) is two brief sequential magnetic pulses that are applied through an air-cooled coil to the section of the head that overlays the motor cortex of the brain.Subjects will be comfortably seated in a dental chair surrounded by a frame that carries a coil holder to assist with the application of TMS to the brain. Paired-pulse transcranial magnetic stimulation (ppTMS) will be administered at 1 month and 6 month visit.
    ARM 1: Kind: Experimental
    Label: Stroke Patients
    Description: Subjects will undergo single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
    ARM 2: Kind: Experimental
    Label: Healthy Controls
    Description: Subjects will undergo single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months.
  • Low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) Device
    Intervention Desc: Low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) is a sequence of brief magnetic pulses that are applied through an air-cooled coil to the section of the head that overlays the motor cortex of the brain.Subjects will be comfortably seated in a dental chair surrounded by a frame that carries a coil holder to assist with the application of TMS to the brain. Low-frequency repetitive transcranial magnetic stimulation (rTMS) will be administered at 1 month and 6 month visit.
    ARM 1: Kind: Experimental
    Label: Stroke Patients
    Description: Subjects will undergo single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
    ARM 2: Kind: Experimental
    Label: Healthy Controls
    Description: Subjects will undergo single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months.
  • Sham Motor Cortex Stimulation Device
    Intervention Desc: Sham motor cortex stimulation will be applied at 1 month and 6 month visit.
    ARM 1: Kind: Experimental
    Label: Stroke Patients
    Description: Subjects will undergo single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
    ARM 2: Kind: Experimental
    Label: Healthy Controls
    Description: Subjects will undergo single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in motor function assessed by the Wolf Motor Function Test (WMFT) Baseline (1 month post stroke), 6 months post stroke No
Primary Change in motor function assessed by the Perdue Pegboard Test Baseline (1 month post stroke), 6 months post stroke No
Primary Change in motor function assessed by the Jebsen Test Baseline (1 month post stroke), 6 months post stroke No
Secondary Change in use of paretic arm assessed by the Motor Activity Log (MAL) Baseline (1 month post stroke), 6 months post stroke No
Secondary Change in primary motor cortex (M1) activity, assessed by Functional Magnetic Resonance Imaging (fMRI) Baseline (1 month post stroke), 6 months post stroke No
Secondary Change in surface electromyographic (EMG) activity to detect electrical activity in the muscles Baseline (1 month post stroke), 6 months post stroke No
Secondary Change in Interhemispheric inhibition (IHI) measured by transcranial magnetic stimulation (TMS) Baseline (1 month post stroke), 6 months post stroke No
Secondary Change in short interval cortical inhibition (SICI) measured by transcranial magnetic stimulation (TMS) Baseline (1 month post stroke), 6 months post stroke No
Secondary Change in active interhemispheric inhibition (aIHI) during pointing task Baseline (1 month post stroke), 6 months post stroke No
Secondary Change in subject's performance in a manual pointing task after contralesional primary motor cortex transcranial magnetic stimulation (TMS) Baseline (1 month post stroke), 6 months post stroke No
Secondary Change in motor threshold after transcranial magnetic stimulation (TMS) Baseline (1 month post stroke), 6 months post stroke No
Secondary Change in mean motor evoked potential (MEP) amplitudes, assessed by stimulus response curve (SRC) Baseline (1 month post stroke), 6 months post stroke No
Secondary Change in short-interval intracortical excitability (SICE) Baseline (1 month post stroke), 6 months post stroke No
Secondary Change in rest interhemispheric inhibition (rIHI) Baseline (1 month post stroke), 6 months post stroke No

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