RecoveriX BCI System Clinical Trial for Stroke Gait Rehabilitation
ClinicalTrials.gov Studies
Summary
NIH's ClinicalTrials.gov registered a new clinical trial (NCT07537530) evaluating the recoveriX PRO Brain-Computer Interface system for gait rehabilitation in stroke patients. The recoveriX device combines motor imagination with functional electrical stimulation and virtual reality feedback, controlled via EEG signals. The trial will enroll stroke patients and compare BCI-assisted therapy (25 sessions over approximately 8 weeks) against standard FES+VR treatment without EEG monitoring to assess safety and functional improvement in gait ability.
What changed
NIH's ClinicalTrials.gov added a new interventional trial registration (NCT07537530) for the recoveriX PRO Brain-Computer Interface system, a Class II medical device combining electroencephalography (EEG), functional electrical stimulation (FES), and virtual reality (VR) feedback for stroke-induced gait rehabilitation. The randomized controlled trial will compare the BCI-assisted therapy (25 sessions at 3 per week) against standard FES+VR therapy without EEG monitoring, assessing gait speed, motor function, and safety in post-stroke patients.
Affected parties—clinical investigators, hospitals, and rehabilitation centers—should note this trial for awareness of upcoming BCI-based stroke rehabilitation research. Sponsors conducting similar stroke or neurorehabilitation device trials should review inclusion/exclusion criteria to ensure their protocols remain competitive. The trial's outcomes may inform future FDA 510(k) or de novo submissions for BCI-FES-VR rehabilitation devices, making this relevant for regulatory affairs and clinical operations teams tracking emerging neuroprosthetics.
Archived snapshot
Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Gait Rehabilitation in Stroke Patients Using Functional Electrical Stimulation and Visual Feedback
N/A NCT07537530 Kind: NA Apr 17, 2026
Abstract
recoveriX PRO system is a Brain-Computer Interface (BCI) device that combines Motor Imagination (MI), with Functional Electrical Stimulation (FES) and Virtual Reality (VR) as feedback devices. The user wears an electroencephalography (EEG) cap that registers the neural activity during the mental practice. This system allows the user to control the feedback devices (FES +VR) with the MI.
The goal of this clinical trial is to know the safety and clinical effectiveness of recoveriX-based treatment for improving gait functions in stroke patients. Researchers will compare the functional results obtained by recoveriX system, to the standard treatment based in FES + VR + MI without monitoring the EEG activity.
The questions to answer are:
- Will stroke patients who undergo recoveriX therapy significantly improve their gait ability?
- Is the functional improvement (gait speed) achieved with the BCI treatment superior to the standard MI+FES+VR treatment?
- Is the recoveriX-based therapy as safe as the standard treatment?
Participants will have to perform a complete assessment to evaluate their functionality before and after the intervention (motor skills, walking ability, impact of the disease in daily living activities).
Patients in the BCI group will receive 25 sessions (3 sessions per week) of BCI training with FES and VR feedback (24 sessions in total).
Patients in the control group will receive 25 sessions (3 sessions per week) of FES + VR therapy. Patients in the con...
Conditions: Stroke
Interventions: recoveriX, Control
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