CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
BCI-FES dorsiflexion therapy +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04279067
NCT04279067N/ACompleted

Brain Computer Interface - Functional Electrical Stimulation (BCI-FES) Therapy for Stroke Rehabilitation

University of California, Irvine·interventional·Posted Feb 20, 2020·Updated Feb 10, 2026

In Brief

A clinical study evaluating BCI-FES dorsiflexion therapy, Physiotherapy one hour, and 1 other intervention for Ischemic Stroke and Hemorrhagic Stroke. Completed, enrolled 62 participants across 1 site.

Detailed Summary

There are over 7 million stroke survivors in the US alone, with approximately 795,000 new cases annually. Despite the best available physiotherapy, 30-60% of stroke survivors remain affected by difficulty walking, with foot weakness often being the main cause. Given that post-stroke gait impairments remain poorly addressed, new methods that can provide lasting improvements are necessary. Brain-computer interface (BCI) technology may be one such novel approach. 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. BCI-FES systems are hypothesized to stimulate recovery after stroke beyond that of conventional physical therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 20, 2020
Enrollment StartMay 15, 2020
Primary CompletionSep 5, 2024
Study CompletionNov 26, 2024
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 6.4 years ago

Interventions

BCI-FES dorsiflexion therapydevice

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.

Physiotherapy one hourbehavioral

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.

Physiotherapy two hoursbehavioral

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.