A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT02098265
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
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 participant'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.
  • RecoveriX — OTHER
    RecoveriX is a brain driven rehabilitation system for stroke patients that pairs mental activities with motor functions.
  • Delay — OTHER
    10 week delay before intervention
  • BCI-FES — DEVICE

Study Details

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.

Key Dates

Start date
Jun 30, 2010
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
288 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group - Immediate BCI Therapy
    EEG - BCI training (closed loop)
  • Experimental: Experimental Group - Delayed BCI Therapy
    Scanned and tested 4 times over a 10-week period before EEG-BCI training
  • Experimental: Experimental Group - RecoveriX
    Recruited from participants who have completed the study intervention
  • Active Comparator: Control Group 1
    48 stroke patients, 48 participants with risk factors for stroke, 48 healthy controls receiving 4-6 training sessions on the EEG-BCI, pre- and post- behavioral testing, and MRI
  • Active Comparator: Control Group 2
    24 Stroke Patients with UE impairment receiving standard FES only therapy

Primary Outcome Measure

Action Research Arm Test Scores [ Time Frame: 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53706
Veena Nair, PhD
[email protected]
608-265-5269

Find similar trials in Madison, WI

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

Related Studies