NCT07537530

Brief Summary

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:

  1. 1.Will stroke patients who undergo recoveriX therapy significantly improve their gait ability?
  2. 2.Is the functional improvement (gait speed) achieved with the BCI treatment superior to the standard MI+FES+VR treatment?
  3. 3.Is the recoveriX-based therapy as safe as the standard treatment?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

April 7, 2026

Last Update Submit

April 16, 2026

Conditions

Stroke

Keywords

Brain-Computer InterfaceNeurofeedbackEEG feedbackElectrical Stimulation TherapyVirtual reality

Outcome Measures

Primary Outcomes (1)

  • 10 Meter Walk Test

    The 10MWT assesses walking speed in meters per second over a short distance and is one of the most used to evaluate functional mobility, gait, and balance for lower limb therapy. This is a metric and continuous variable. The 10MWT is used for clinical purposes and in research. It supports the assessment of the degree of damage and describes the recovery of lower extremity after a stroke. Individuals walk 10 meters without assistance and the time is measured for the intermediate 6 meters to allow for acceleration and deceleration. Assistive devices can be used but should be kept consistent and documented from test to test. If physical assistance is required to walk, the 10MWT should not be performed. Patients will receive the following instructions: "Walk as fast as you can safely walk and stop when you reach the far mark."

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

  • Timed Up and Go test

    From enrollment to the end of treatment at 8 weeks

  • Modified Ashworth Scale

    From enrollment to the end of treatment at 8 weeks

Study Arms (2)

BCI

EXPERIMENTAL

Patients in the BCI group will receive 25 sessions (3 times per week) of BCI training with FES and VR feedback.

Device: recoveriX

Control

SHAM COMPARATOR

Patients in the control group receive 25 sessions (3 times per week) of FES and VR therapy. Patients in the control group will receive the same instructions as the experimental but will not wear the EEG cap.

Device: Control

Interventions

recoveriXDEVICE

The intervention utilizes the recoveriX PRO system. This is a neurofeedback therapy device that combines Brain-Computer Interface based motor imagery, functional electrical stimulation (FES), and virtual reality (VR). This approach enables participants to engage in motor imagery exercises while receiving real-time feedback based on neural signals. Participants will complete a total of 25 recoveriX sessions, scheduled at 3 sessions per week, with each session lasting 1 hour.

Also known as: Brain-Computer Interface with FES and VR
BCI
ControlDEVICE

The participants will train the Motor Imagination (MI) combined with Functional Electrical Stimulation (FES) and Virtual Reality (VR) feedback. Feedback provided to the patients will not be linked to the neural signals. The amount of stimulation delivered by the feedback devices (FES and VR) will be similar to the experimental group.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • months or more post stroke
  • With a restriction of the lower extremities preventing the persons from activities of daily life
  • Participants must be German speaking.
  • Demonstrate intact cognition to provide informed consent and follow instructions.
  • Be able to perform TUG and 10MWT (3 times).

You may not qualify if:

  • Debilitating conditions or vision impairment that would impede full participation in the study.
  • Other neurological conditions affecting the motor system or the compliance to the therapy (for example Polyneuropathy or Musculoskeletal Diseases).
  • Uncontrolled epilepsy or seizures
  • Significant circulatory disturbances of the stimulated extremities
  • Inability to independently maintain the seated position (without assistance) for about 60 minutes.
  • Pregnant
  • Active or passive implanted medical devices such as pacemakers which do not allow the use of FES.
  • Implanted metallic fragments in the upper and lower extremities which can limit the use of FES.
  • Under the influence of anesthesia or similar medication.
  • With fractures or lesions in the extremity to be stimulated.
  • Inadequate control of a BCI system.
  • Sensory disorders which can significantly affect the patient's ability to feel pain and to react to unsuitable proprioceptive stimuli.
  • Botulinum toxin treatment of his/her paretic lower limb during this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

g.tec medical engineering GmbH

Schiedlberg, Upper Austria, 4521, Austria

Location

Related Publications (5)

  • Sebastian-Romagosa M, Cho W, Ortner R, Sieghartsleitner S, Von Oertzen TJ, Kamada K, Laureys S, Allison BZ, Guger C. Brain-computer interface treatment for gait rehabilitation in stroke patients. Front Neurosci. 2023 Oct 18;17:1256077. doi: 10.3389/fnins.2023.1256077. eCollection 2023.

    PMID: 37920297BACKGROUND

  • Sebastian-Romagosa M, Cho W, Ortner R, Murovec N, Von Oertzen T, Kamada K, Allison BZ, Guger C. Brain Computer Interface Treatment for Motor Rehabilitation of Upper Extremity of Stroke Patients-A Feasibility Study. Front Neurosci. 2020 Oct 21;14:591435. doi: 10.3389/fnins.2020.591435. eCollection 2020.

    PMID: 33192277BACKGROUND

  • Sebastian-Romagosa M, Udina E, Ortner R, Dinares-Ferran J, Cho W, Murovec N, Matencio-Peralba C, Sieghartsleitner S, Allison BZ, Guger C. EEG Biomarkers Related With the Functional State of Stroke Patients. Front Neurosci. 2020 Jul 7;14:582. doi: 10.3389/fnins.2020.00582. eCollection 2020. Erratum In: Front Neurosci. 2022 Sep 23;16:1032959. doi: 10.3389/fnins.2022.1032959.

    PMID: 32733182BACKGROUND

  • Sieghartsleitner S, Sebastian-Romagosa M, Cho W, Grunwald J, Ortner R, Scharinger J, Kamada K, Guger C. Upper extremity training followed by lower extremity training with a brain-computer interface rehabilitation system. Front Neurosci. 2024 Mar 4;18:1346607. doi: 10.3389/fnins.2024.1346607. eCollection 2024.

    PMID: 38500488BACKGROUND

  • de Castro-Cros M, Sebastian-Romagosa M, Rodriguez-Serrano J, Opisso E, Ochoa M, Ortner R, Guger C, Tost D. Effects of Gamification in BCI Functional Rehabilitation. Front Neurosci. 2020 Aug 21;14:882. doi: 10.3389/fnins.2020.00882. eCollection 2020.

    PMID: 32973435BACKGROUND

Related Links

MeSH Terms

Conditions

Stroke

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 17, 2026

Study Start

June 3, 2025

Primary Completion

April 2, 2026

Study Completion

April 2, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)