Recruiting

Stroke Rehabilitation Device

Sponsor:

University of Wisconsin, Madison

Code:

NCT02098265

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Functional Electric Stimulation (FES)

Behavioral Assessments

Magnetic Resonance Imaging

EEG

RecoveriX

Study Details

Brief summary:

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.

Conditions

Stroke

Study ID

NCT02098265

Start date

Jun, 2010

Status verified date

May, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria (Experimental Group):

  • Stroke patients with persistent upper extremity (UE) deficits

Inclusion Criteria (Control Group 1)

  • Stroke patients without UE impairments
  • Participants with risk factors for stroke
  • healthy controls

  • No known neurologic, psychiatric or developmental disability

Inclusion Criteria (Control Group 2)

  • Stroke patients with persistent upper extremity (UE) deficits
  • Moderate upper extremity (dominant right hand affected) impairment (score of 1 or 2 on the motor sub-component of the NIH stroke scale (NIHSS) and ARAT score 20-45)
  • No upper extremity injury or conditions that limited use prior to the stroke
  • Pre-stroke independence with a Modified Rankin Score of 0 or 1, for the standard FES only intervention.

Exclusion Criteria (for all participants):

  • Allergic to electrode gel, surgical tape and metals
  • Participants under treatment for infectious diseases or having apparent oral lesions or inflammation will be excluded from the study
  • Women who are pregnant or may become pregnant during the course of the study will be excluded
  • Participants with contraindications for MRI will be offered the opportunity to participate in the interventions study only (e.g. EEG-BCI-FES and behavioral testing)

Exclusion Criteria (for healthy controls)

  • Contraindications for MRI
  • Allergic to electrode gel, surgical tape, and metals.

Study Design

Enrollment

288 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Functional Electric Stimulation (FES)

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

These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.

Magnetic Resonance Imaging

A functional magnetic resonance image will be collected.

EEG

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

RecoveriX is a brain driven rehabilitation system for stroke patients that pairs mental activities with motor functions.

Delay

10 week delay before intervention

BCI-FES

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Radiology Studies

608-282-8349Radstudy@uwhealth.org

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53706

Contacts

Veena Nair, PhD

608-265-5269vnair@uwhealth.org

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • aneurysm
  • transient ischemic attack

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-05-15.