A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device

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

Interventions

DEVICE

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

Behavioral Assessments

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

OTHER

Magnetic Resonance Imaging

A functional magnetic resonance image will be collected.

OTHER

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.

OTHER

RecoveriX

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

OTHER

Delay

10 week delay before intervention

DEVICE

BCI-FES

Sponsors & Collaborators

• University of Wisconsin, Madison

  lead OTHER

• American Heart Association

  collaborator OTHER

Principal Investigators

• Vivek Prabhakaran, MD, PhD · University of Wisconsin, Madison

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2027-06-30

Completion

2027-06-30

FDA Device

Yes

Countries

• United States

Study Locations