Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT04141774
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Functional Electric Stimulation (FES) — DEVICE
    FES uses low energy electrical pulses to artificially generate body movements in individuals with muscle paralysis. FES can be used to generate muscle contraction in otherwise paralyzed limbs to restore function.
  • Behavioral Assessments — BEHAVIORAL
    These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.
  • Magnetic Resonance Imaging — OTHER
    A functional magnetic resonance image will be collected.
  • EEG — OTHER
    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.

Study Details

The purpose of this research is to determine if functional muscle stimulation, 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 (fMRI). Participants will include stroke patients with upper-limb hemiparesis and can expect to be on study for approximately 4 months.

Key Dates

Start date
Sep 27, 2018
Status verified
Oct 2025
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

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

Arms

  • Active Comparator: Passive FES
    Subjects randomized to this control group will be asked to participate in a passive FES intervention or non-EEG guided muscle stimulation. Participation will include behavioral assessments, functional magnetic resonance imaging, and functional electric stimulation (FES) treatment.
  • Experimental: Active FES
    Subjects randomized to this experimental group will be asked to complete the active FES intervention which include EEG guided muscle stimulation. Participation will include behavioral assessments, functional magnetic resonance imaging, functional electric stimulation (FES) treatment, and EEG.

Primary Outcome Measure

Action Research Arm Test Scores [ Time Frame: baseline, 7 weeks, 10 weeks, 4 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53706-

Find similar trials in Madison, WI

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University of Wisconsin· Madison, WI

Related Studies