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Procedure

BCI-FES Therapy for Stroke Rehabilitation

N/A
Recruiting
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Can walk > 10 m (with or without ankle foot orthosis (AFO), and cane or walker permitted) at a supervised level
Passive Range of Motion at least 0 degrees ankle dorsiflexion in subtalar neutral or with FES
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change gait endurance (six minute walk test: 6mwt) from screening to 1 month
Awards & highlights

Study Summary

This trial is testing whether BCI-FES systems can improve foot movement and walking ability in people who have had a stroke.

Who is the study for?
This trial is for stroke survivors aged 18-80, at least 26 weeks post-stroke, with walking difficulties due to foot weakness. They must be able to walk over 10 meters and tolerate FES therapy. Excluded are those with recent Botox in legs, severe depression, other major medical issues affecting gait, concurrent physical therapy or investigational studies, implanted electronic devices or metal in the skull.Check my eligibility
What is being tested?
The study tests a new rehab method using brain-computer interface (BCI) combined with functional electrical stimulation (FES) against standard physiotherapy. It aims to see if this tech can better improve walking after a stroke by directly controlling assistive devices through brain waves.See study design
What are the potential side effects?
Potential side effects may include discomfort from FES like mild pain not exceeding a moderate level on pain scales and skin irritation at the stimulation sites. There's also a risk of fatigue from increased activity during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk more than 10 meters, even if I need a cane, walker, or AFO.
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I can move my ankle upwards to a flat position without help.
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I am between 18 and 80 years old.
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I can handle electrical stimulation with minimal pain and my foot lifts properly.
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I walk slower than 0.8 meters per second.
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I had a stroke confirmed by imaging at least 26 weeks ago.
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I have foot-drop in my limb, with limited movement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change gait endurance (six minute walk test: 6mwt) from screening to 1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and change gait endurance (six minute walk test: 6mwt) from screening to 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Gait Velocity
Secondary outcome measures
Change Gait Endurance (Six minute walk test: 6MWT)
Change Leg Motor Fugl-Meyer score (Leg FM)
Change in Dorsiflexion Range of Motion
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose-and intensity-matched physiotherapyExperimental Treatment1 Intervention
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.
Group II: BCI-FES dorsiflexion therapy with physiotherapyExperimental Treatment2 Interventions
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.

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
537 Previous Clinical Trials
1,921,574 Total Patients Enrolled

Media Library

BCI-FES dorsiflexion therapy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04279067 — N/A
Hemorrhagic Stroke Research Study Groups: BCI-FES dorsiflexion therapy with physiotherapy, Dose-and intensity-matched physiotherapy
Hemorrhagic Stroke Clinical Trial 2023: BCI-FES dorsiflexion therapy Highlights & Side Effects. Trial Name: NCT04279067 — N/A
BCI-FES dorsiflexion therapy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04279067 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial open to individuals who are of advanced age?

"The requirements for being eligible to participate in this trial stipulate that suitable candidates must be between 18 and 80 years of age. There are 40 studies looking at minors, while 1058 focus on those over 65."

Answered by AI

Are there currently any enrollment openings for this clinical experiment?

"Yes, the clinicaltrials.gov website affirms that this medical study is in the process of recruiting participants. The first recruitment post was published on May 15th 2020 and has been updated as recently as September 15th 2022; it seeks to enrol 80 patients from a single centre."

Answered by AI

What is the projected sample size of participants for this clinical trial?

"Affirmative. The clinical trial listing hosted on clinicaltrials.gov indicates that the study is actively seeking participants, with 80 individuals required at a single site since it was posted on May 15th 2020 and updated most recently in September 2022."

Answered by AI

Are my qualifications sufficient to participate in this investigation?

"Participants aged 18 to 80 with a recent wake-up stroke are being recruited for this clinical trial. This research is seeking out individuals who have radiologically confirmed strokes, spasticity scores of less than three on the modified Ashworth Scale, pain tolerance no greater than four on an analog scale, adequate muscle response in dorsiflexion of at least 10 degrees or more and passive range of motion (PROM) at 0 degrees or higher in subtalar neutral when using FES technology. Additionally all participants must be able to walk over 10m without ankle foot orthosis (AFO), canes and/or walkers permitted but"

Answered by AI
~4 spots leftby Jul 2024