A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device

Recruiting

Phase N/A Results N/A

Trial Description

The purpose of this research is to determine if two non-invasive brain stimulation techniques, muscle stimulation of the arm and neuro-stimulation through the tongue, can increase the extent of stroke recovery.

Detailed Description

The aim of this study is to determine if functional muscle stimulation, in addition to non-invasive neurostimulation through the tongue, directed by electroencephalogram (EEG) output, can increase the extent of stroke recovery on behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging. Forty-four adult stroke patients and 5 healthy controls will be recruited in this study.

Conditions

Interventions

  • Transcranial Magnetic Stimulation Device
    Intervention Desc: Electrical stimulation of the brain, through direct cortical stimulation
    ARM 1: Kind: Experimental
    Label: Control
    Description: All subjects enrolled will be asked to complete the study interventions which include behavioral assessments, magnetic resonance imaging, functional electric stimulation treatment or Transcranial Magnetic Stimulation, and EEG.
    ARM 2: Kind: Experimental
    Label: Patient
    Description: All subjects enrolled will be asked to complete the study interventions which include behavioral assessments, magnetic resonance imaging, functional electric stimulation treatment or Transcranial Magnetic Stimulation, and EEG.
  • Magnetic Resonance Imaging Diagnostic Test
    Other Names: MRI
    Intervention Desc: A functional magnetic resonance image will be collected.
    ARM 1: Kind: Experimental
    Label: Control
    Description: All subjects enrolled will be asked to complete the study interventions which include behavioral assessments, magnetic resonance imaging, functional electric stimulation treatment or Transcranial Magnetic Stimulation, and EEG.
    ARM 2: Kind: Experimental
    Label: Patient
    Description: All subjects enrolled will be asked to complete the study interventions which include behavioral assessments, magnetic resonance imaging, functional electric stimulation treatment or Transcranial Magnetic Stimulation, and EEG.
  • EEG Other
    Other Names: Electroencephalography
    Intervention Desc: EEG electrodes will be attached to the subject's scalp using a standard, commercially available electrode cap. Proper electrode placement is made according to the international 10-20 system, ensuring complete electrode coverage over sensorimotor cortex.
    ARM 1: Kind: Experimental
    Label: Control
    Description: All subjects enrolled will be asked to complete the study interventions which include behavioral assessments, magnetic resonance imaging, functional electric stimulation treatment or Transcranial Magnetic Stimulation, and EEG.
    ARM 2: Kind: Experimental
    Label: Patient
    Description: All subjects enrolled will be asked to complete the study interventions which include behavioral assessments, magnetic resonance imaging, functional electric stimulation treatment or Transcranial Magnetic Stimulation, and EEG.
  • Behavioral Assessments Behavioral
    Intervention Desc: These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.
    ARM 1: Kind: Experimental
    Label: Control
    Description: All subjects enrolled will be asked to complete the study interventions which include behavioral assessments, magnetic resonance imaging, functional electric stimulation treatment or Transcranial Magnetic Stimulation, and EEG.
    ARM 2: Kind: Experimental
    Label: Patient
    Description: All subjects enrolled will be asked to complete the study interventions which include behavioral assessments, magnetic resonance imaging, functional electric stimulation treatment or Transcranial Magnetic Stimulation, and EEG.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Efficacy 4 months No
Secondary Functional 4 months No
Primary Action Research Arm Test results 4 months No
Secondary EEG response strength 4 months No
Secondary Signal change in functional MRI 4 month No

Sponsors