BCI-FES Therapy for Stroke Rehabilitation

NACompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

May 15, 2020

Primary Completion Date

September 5, 2024

Study Completion Date

November 26, 2024

Conditions
Ischemic StrokeHemorrhagic Stroke
Interventions
DEVICE

BCI-FES dorsiflexion therapy

"BCI technology enables direct brain control of external devices such as assistive devices and prostheses by translating brain waves into control signals. When BCI systems are integrated with functional electrical stimulation (FES) systems, they can be used to deliver a novel physical therapy to improve movement after stroke. The automated software will analyze the data to generate and calibrate a BCI decoder. In the online phase, the subjects will perform 20-25 BCI-FES runs. In each run, subjects will follow 10 alternating epochs of 10-s long idling/dorsiflexion textual cues, and respond by either idling or attempting dorsiflexion to elicit BCI-FES mediated contractions of the TA muscle."

BEHAVIORAL

Physiotherapy one hour

This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises. A total of 12 sessions will be performed at 3x/week.

BEHAVIORAL

Physiotherapy two hours

This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises. A total of 12 sessions will be performed at 3x/week.

Trial Locations (1)

92697

University of California, Irvine - Sue & Bill Gross Stem Cell Research Center, Irvine

All Listed Sponsors
lead

University of California, Irvine

OTHER

NCT04279067 - BCI-FES Therapy for Stroke Rehabilitation | Biotech Hunter | Biotech Hunter