BCI-FES Therapy for Stroke Rehabilitation

NCT04279067 | Completed Results DMC FDA Device

• 1 other identifier: 20194936
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke; Hemorrhagic Stroke

Keywords

stroke

Outcome Measures

Primary Outcomes (1)

• Gait Velocity

  Gait velocity will be assessed by measuring the time to traverse the middle 6 m of a 10-m walkway (5 repetitions/assessment). Scores are reported in meters/second with higher scores indicating better function.

  Baseline to End of Therapy (4 weeks after initiation of therapy)

Secondary Outcomes (4)

• Dorsiflexion Range of Motion

  Baseline and end of therapy (4 weeks after initiation of therapy)

• Gait Endurance (Six Minute Walk Test: 6MWT)

  Baseline to End of Therapy (4 weeks after initiation of therapy)

• Fall Frequency

  Baseline to End of Therapy (4 weeks after initiation of therapy)

• EEG Map (Electroencephalogram)

  Baseline to End of Therapy (4 weeks after initiation of therapy)

Study Arms (2)

BCI-FES dorsiflexion therapy with physiotherapy

EXPERIMENTAL

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.

Device: BCI-FES dorsiflexion therapy; Behavioral: Physiotherapy one hour

Dose-and intensity-matched physiotherapy

EXPERIMENTAL

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.

Behavioral: Physiotherapy two hours

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.

BCI-FES dorsiflexion therapy with physiotherapy

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.

BCI-FES dorsiflexion therapy with physiotherapy

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.

Dose-and intensity-matched physiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age18-80 years inclusively at time of consent;
• Radiologically confirmed stroke, ischemic or intracerebral hemorrhage (ICH) in etiology, with day of onset at least 26 weeks prior to day of randomization
• Gait velocity\<0.8 m/s at screening and baseline visits.
• Foot-drop in affected limb as defined by dorsiflexion active range of motion (AROM) via goniometry in seated position foot dangling is less than passive range of motion and less than 15 degrees.
• Plantarflexors spasticity\<3 on modified Ashworth Scale;
• Can walk \>10 m (with or without ankle foot orthosis (AFO), and cane or walker permitted) at a supervised level;
• Can tolerate FES with pain no more than 4 on pain analog scale and has adequate muscle response of dorsiflexion ≥10 degrees;
• Passive Range of Motion at least 0 degrees ankle dorsiflexion in subtalar neutral or with FES

You may not qualify if:

• A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures or safely complete study procedures. This includes, but not limited to documented serious cardiac conditions, serious pulmonary conditions, legal blindness, end stage renal or liver disease, pulmonary embolism or deep venous thrombosis.
• Resting systolic blood pressure above 170, diastolic blood pressure above 100 at screening and baseline evaluations
• Implanted electronic device (e.g. pacemaker) or skull metallic implants (e.g. cranioplasty plate covering the leg motor area);
• Deficits in communication that interfere with reasonable study participation: language or attention impairment (score\>1 on NIH Stroke Scale items 9 and 11, respectively)
• A new symptomatic stroke occurs apart from the index stroke during the screening process and prior to randomization
• Life expectancy \< 6 months
• Skin breakdown over electrical stimulation sites;
• Received chemical denervation (eg Botox) to legs in the preceding 6 months, or expectation that chemical denervation will be administered to the leg prior to expected completion of the study
• Unable or unwilling to perform study procedures/therapy, or expectation of non-compliance with study procedures/therapy
• Pregnancy;
• Significant pain (visual analog scale \>4), chest pain, or shortness of breath with walking.
• Receiving any outside concurrent physical therapy involving the lower extremities after enrollment in the study up to 1 month post treatment
• Any general medical condition and psychosocial situation that substantially interferes with reasonable participate in study appointments
• Non-English speaking, such that subject does not speak sufficient English to comply with study procedures
• Concurrent enrollment in another investigational interventional study

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

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

Irvine, California, 92697, United States

Location

Related Publications (1)

• Biswas P, Dodakian L, Wang PT, Johnson CA, See J, Chan V, Chou C, Lazouras W, McKenzie AL, Reinkensmeyer DJ, Nguyen DV, Cramer SC, Do AH, Nenadic Z. A single-center, assessor-blinded, randomized controlled clinical trial to test the safety and efficacy of a novel brain-computer interface controlled functional electrical stimulation (BCI-FES) intervention for gait rehabilitation in the chronic stroke population. BMC Neurol. 2024 Jun 13;24(1):200. doi: 10.1186/s12883-024-03710-3.

  PMID: 38872109 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Stroke

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Results Point of Contact

• Title: An Do, MD
• Organization: University of California, Irvine

and@uci.edu

714-456-2332

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors will be blinded to the whether participants are in Group 1 or 2.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor, Department of Neurology

Model Details: The study is design as an early Phase II two-arm randomized trial. The experimental group will receive BCI-FES dorsiflexion therapy paired with conventional physiotherapy (Group 1), while the control arm will receive dose- and intensity-matched conventional physiotherapy (Group 2). A total of 80 chronic stroke survivors with gait impairment due to foot-drop will be recruited and randomized evenly into the 2 groups (33/group).

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 20, 2020
• Study Start: May 15, 2020
• Primary Completion: September 5, 2024
• Study Completion: November 26, 2024
• Last Updated: February 10, 2026
• Results First Posted: February 10, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)