BCI-FES Therapy for Stroke Rehabilitation

Part of paid clinical trials in Irvine, California.

Sponsor
University of California, Irvine
Study ID
NCT04279067
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • BCI-FES dorsiflexion therapy — DEVICE
    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 hour — BEHAVIORAL
    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 hours — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 15, 2020
Status verified
Dec 2025
Primary completion
Sep 5, 2024
Completion
Nov 26, 2024

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BCI-FES dorsiflexion therapy with physiotherapy
    Subjects will undergo placement of an EEG cap using standard technique connected to our custom BCI system. Subjects will provide 5 min of training EEG data as they engage in alternating epochs of idling and attempted foot dorsiflexion (of the paretic side). In the online phase, the subjects will perform 20-25 BCI-FES runs. A total of 12 sessions will be performed at a rate of 3x/week (over 4 weeks). Each BCI-FES therapy session will be followed by 1 hour of conventional physiotherapy. Conventional Physical Therapy: 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.
  • Experimental: Dose-and intensity-matched physiotherapy
    Conventional Physical Therapy: 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. In the dose-matched control group (Group 2), it will be 2 hours/session.

Primary Outcome Measure

Gait Velocity [ Time Frame: Baseline to End of Therapy (4 weeks after initiation of therapy) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Irvine - Sue & Bill Gross Stem Cell Research CenterIrvineCalifornia92697-

Find similar trials in Irvine, CA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University of California, Irvine - Sue & Bill Gross Stem Cell Research Center· Irvine, CA

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