Ischemic StrokeNCT04279067
BCI-FES Therapy for Stroke Rehabilitation
A study testing BCI-FES dorsiflexion therapy, Physiotherapy one hour and Physiotherapy two hours in people with Ischemic Stroke and Hemorrhagic Stroke, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Hemorrhagic Stroke
- What is being tested?
- BCI-FES dorsiflexion therapy, Physiotherapy one hour and Physiotherapy two hours
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2020to 26 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- A major, active, coexistent medical, neurological (apart from stroke) or psychiatric disease (apart from stroke), including alcoholism or dementia, orthopedic injuries, that substantially affects gait. **Because old orthopedic injuries may or may not affect gait, at the discretion of the site's study PI, exclusion criterion #2 related to orthopedic injuries can be waived if the injury was not on the stroke affected side and the joint/muscles are back to normal motor and range of motion function.
- 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)
- Significant cognitive impairment, defined as Montreal Cognitive Assessment score < 22 (For those with aphasia: **Because Montreal Cognitive Assessment scores may be difficult to interpret for patients with aphasia, at the discretion of the site's study PI, exclusion criterion #5 ("MoCA score cannot be <22") can be waived)
Show all 30Show fewer
- 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
- Severe depression, defined as Geriatric Depression Scale Score >11: **Because Geriatric Depression scale scores may be difficult to interpret for some patients, at the discretion of the site's study PI, exclusion criterion #17 ("Geriatric Depression score cannot be >11") can be waived)
- Concurrent use of FES orthosis for gait.
- A new symptomatic stroke occurs apart from the index stroke during the screening process and prior to randomization
- If TMS Eligible (note that potential subjects who do not qualify for TMS will not be excluded from the main study, they will only be excluded from undergoing TMS procedures):
- TMS: Metallic hardware on the scalp (e.g. vascular clips or cranioplasty mesh)
- TMS: Implanted medication pumps, intracardiac line, or central venous catheter
- TMS: History of cortical stroke or other cortical lesion such as brain tumor
- TMS: Prior diagnosis of seizure or epilepsy
- TMS: Any electrical, mechanical, or magnetic implants
- TMS: History of neurosurgery
- TMS: uncontrolled Migraine headaches
- TMS: Any current medications that affect seizure threshold such as tricyclic antidepressants and neuroleptics
- TMS: Unstable medical conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine - Sue & Bill Gross Stem Cell Research Center
Irvine, California, 92697
About this study
Official title: Brain Computer Interface - Functional Electrical Stimulation (BCI-FES) Therapy for Stroke Rehabilitation
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.
Read the detailed description
Preliminary research indicates that applying this technique to foot weakness after stroke is safe and may improve walking function. Hence, this warrants further investigation to: 1. determine if BCI-FES therapy can provide lasting gains in walking in chronic stroke patients; 2. determine what factors influence BCI-FES therapy; and 3. explicitly elucidate the underlying neural repair mechanisms. First, a Phase II clinical trial in patients with foot drop due to chronic stroke will compare the effect of BCIFES dorsiflexion therapy to that of dose- and intensity-matched standard physical therapy (Aim 1). Comparing the improvement in walking speed and other secondary outcome measures between the two groups will test if BCI-FES therapy provides functional and neurological gains beyond those of standard physical therapy. The relationship between the patient baseline characteristics (walking speed, ankle function, stimulated muscle responses, brain wave features, sensation) and the outcomes will determine what features influence responsiveness to BCI-FES dorsiflexion therapy (Aim 2). Finally, the underlying mechanism driving the improvements of BCI-FES will be studied (Aim 3). Determining that BCI-FES therapy can provide improvements beyond that of standard therapy may lead to a new treatment for stroke patients. The underlying mechanism can inform the design of future physical therapy techniques or improve current ones. Finally, BCI-FES therapy may ultimately become a novel form of physical therapy to reduce post-stroke disability, and in turn reduce the public health burden of stroke.
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke
- Being tested
- BCI-FES dorsiflexion therapy, Physiotherapy one hour, Physiotherapy two hours
- Keywords
- stroke
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 hourBehavioural
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 hoursBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Physiotherapy two hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to End of Therapy (4 weeks after initiation of therapy)
Secondary outcomes (4)
Dorsiflexion Range of Motion
The paretic foot will be placed in a dangling, subtalar neutral position idling, while the tibia is perpendicular to the ground and the femur horizontal to the ground. A goniometer will be used to measure the maximum dorsiflexion angle, in degrees. 0 degrees indicates a neutral ankle position (foot horizontal to the ground, while tibia is perpendicular to the ground). Positive degrees indicate a maximum dorsiflexion angle above the neutral position, while negative degrees indicates a maximum angle below the neutral position (a larger, more positive measure indicates higher function).
Measured: Baseline and end of therapy (4 weeks after initiation of therapy)
Gait Endurance (Six Minute Walk Test: 6MWT)
The distance walked over 6 minutes. Score is reported in meters and higher score indicates better function.
Measured: Baseline to End of Therapy (4 weeks after initiation of therapy)
Fall Frequency
Rate of falls experienced by subjects
Measured: Baseline to End of Therapy (4 weeks after initiation of therapy)
EEG Map (Electroencephalogram)
Subjects will undergo 64-channel EEG recording as they engage in 100 alternating 10-s long epochs of idling and attempted dorsiflexion. The EEG modulation, defined as the change in alpha (8-12 Hz) and beta (13-30 Hz) band power during attempted dorsiflexion (compared to idling) will be calculated and averaged over all epochs and across all channels. Change in EEG alpha and beta band power will be express as percentage with respect to the idle state. Specifically, the change in the Channel Cz will be reported given its primary salience to attempted dorsiflexion.
Measured: Baseline to End of Therapy (4 weeks after initiation of therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start15 May 2020
- Primary completion5 Sep 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, An Do, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279067
- Sponsor's protocol ID
- 20194936
- Status last verified
- Dec 2025
- First submitted
- 12 Feb 2020
- Last updated
- 10 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38872109
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Computer Interface - Functional Electrical Stimulation (BCI-FES) Therapy for Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT04279067
- Acronym / sponsor ID
- 20194936
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke
- Keywords
- stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Posted 10 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preliminary research indicates that applying this technique to foot weakness after stroke is safe and may improve walking function. Hence, this warrants further investigation to: 1. determine if BCI-FES therapy can provide lasting gains in walking in chronic stroke patients; 2. determine what factors influence BCI-FES therapy; and 3. explicitly elucidate the underlying neural repair mechanisms. First, a Phase II clinical trial in patients with foot drop due to chronic stroke will compare the effect of BCIFES dorsiflexion therapy to that of dose- and intensity-matched standard physical therapy (Aim 1). Comparing the improvement in walking speed and other secondary outcome measures between the two groups will test if BCI-FES therapy provides functional and neurological gains beyond those of standard physical therapy. The relationship between the patient baseline characteristics (walking speed, ankle function, stimulated muscle responses, brain wave features, sensation) and the outcomes will determine what features influence responsiveness to BCI-FES dorsiflexion therapy (Aim 2). Finally, the underlying mechanism driving the improvements of BCI-FES will be studied (Aim 3). Determining that BCI-FES therapy can provide improvements beyond that of standard therapy may lead to a new treatment for stroke patients. The underlying mechanism can inform the design of future physical therapy techniques or improve current ones. Finally, BCI-FES therapy may ultimately become a novel form of physical therapy to reduce post-stroke disability, and in turn reduce the public health burden of stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| BCI-FES dorsiflexion therapy with physiotherapy | Experimental | Device: BCI-FES dorsiflexion therapy, Behavioral: Physiotherapy one hourSubjects 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. |
| Dose-and intensity-matched physiotherapy | Experimental | Behavioral: Physiotherapy two hoursConventional 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (30 listed)
- A major, active, coexistent medical, neurological (apart from stroke) or psychiatric disease (apart from stroke), including alcoholism or dementia, orthopedic injuries, that substantially affects gait. **Because old orthopedic injuries may or may not affect gait, at the discretion of the site's study PI, exclusion criterion #2 related to orthopedic injuries can be waived if the injury was not on the stroke affected side and the joint/muscles are back to normal motor and range of motion function.
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCI-FES dorsiflexion therapyBCI 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. | Device | BCI-FES dorsiflexion therapy with physiotherapy |
| Physiotherapy one hourThis 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. | Behavioural | BCI-FES dorsiflexion therapy with physiotherapy |
| Physiotherapy two hoursThis 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. | Behavioural | Dose-and intensity-matched physiotherapy |
Primary outcome
Gait Velocity
Time frame: Baseline to End of Therapy (4 weeks after initiation of therapy)
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.
4 secondary outcomes
Dorsiflexion Range of Motion
Time frame: Baseline and end of therapy (4 weeks after initiation of therapy)
Gait Endurance (Six Minute Walk Test: 6MWT)
Time frame: Baseline to End of Therapy (4 weeks after initiation of therapy)
Fall Frequency
Time frame: Baseline to End of Therapy (4 weeks after initiation of therapy)
EEG Map (Electroencephalogram)
Time frame: Baseline to End of Therapy (4 weeks after initiation of therapy)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38872109Biswas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCI-FES dorsiflexion therapy, Physiotherapy one hour and Physiotherapy two hours in people with Ischemic Stroke and Hemorrhagic Stroke, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Velocity (time frame: Baseline to End of Therapy (4 weeks after initiation of therapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.