Parkinson DiseaserecoveriX PDNCT06690931
Neurofeedback Rehabilitation With FES and VR for PD
A study testing Brain-Computer Interface with FES and VR and Motor imagery with Functional Electrical Stimulation and Virtual Reality feedback in people with Parkinson Disease, run by g.tec medical engineering GmbH at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Brain-Computer Interface with FES and VR and Motor imagery with Functional Electrical Stimulation and Virtual Reality feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 9 Dec 2024to 25 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PD
- HY stage between 1 to 3
- Age between 40 - 80 years old
- Ability to walk independently
- Stable medication usage
- Stable neurological condition
- Able to sign the informed consent.
- Able to follow the study protocol.
Who cannot join
- Other neurological diseases
- Severe depression
- Uncontrolled diabetes
- Concomitant severe neurologic, cardiopulmonary, or orthopedic disorders
- Debilitating conditions or vision impairment that would impede full participation in the study.
- Unpredictable motor fluctuations
Show all 12Show fewer
- 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 upper and lower extremities.
- Inadequate control of a BCI system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parkinson's Disease Rehabilitation Using Neurofeedback With Functional Electrical Stimulation and Virtual Reality Feedback for Lower Extremities
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 motor functions in Parkinson's Disease 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.
Read more
The questions to answer are:
- Will Parkinson's patients who undergo recoveriX therapy significantly improve their motor functions?
- Is the functional improvement 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, fatigue, impact of the disease in daily living activities).
Patients in the BCI group will receive 6 sessions per week during 4 weeks of BCI training with FES and VR feedback (24 sessions in total).
Patients in the control group receive 6 sessions of FES + VR therapy per week for 4 weeks (24 sessions in total). Patients in the control group will receive the same instructions as the experimental but will not wear the EEG cap.
- Conditions
- Parkinson Disease
- Being tested
- Brain-Computer Interface with FES and VR, Motor imagery with Functional Electrical Stimulation and Virtual Reality feedback
- Keywords
- Brain-Computer Interface, Neurofeedback, EEG Feedback, Electrical Stimulation Therapy, Virtual reality
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-Computer Interface with FES and VRDevice
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 24 recoveriX sessions, scheduled at 6 sessions per week, with each session lasting 1 hour.
Motor imagery with Functional Electrical Stimulation and Virtual Reality feedbackDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| BCI group | Experimental | Patients in the BCI group will receive 6 sessions per week during 4 weeks of BCI training with FES and VR feedback (24 sessions in total). Receives: Device: Brain-Computer Interface with FES and VR |
| Control group | Sham comparator | Patients in the control group receive 6 sessions of Motor Imagery + FES + VR therapy per week for 4 weeks (24 sessions in total). Patient in the control group will receive the same instructions as the experimental group. Receives: Device: Motor imagery with Functional Electrical Stimulation and Virtual Reality feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Disorders Society - Unified Parkinson's Disease Rating Scale Section III
Motor examination.
Measured: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
Secondary outcomes (8)
Movement Disorders Society - Unified Parkinson's Disease Rating Scale - Sections I, II, IV
This scale assesses: Section I - Non-motor activities of daily living; Section II - Motor activities of daily living; Section IV - Motor complications.
Measured: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
Parkinson's Disease Questionnaire
The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. It also assesses the impact of Parkinson's on specific dimensions of functioning and wellbeing.
This scale has 39 items, each item has a 5-point ordinal scoring system. The scale ranges from 0 to 156, where low values are related with better quality of life (QoL) and high values to low QoL.
Measured: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
Modified Fatigue Impact Scale
The MFIS is a modified form of the Fatigue Impact Scale (Fisk et al. 1994) based on items derived from interviews with PD patients concerning how fatigue impacts their lives. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning.
Participants rate on a 5-point Likert scale, with 0='Never' to 4='Almost always' their agreement with 21 statements. Total scale (0-84) and subscales for physical (0-36), cognitive (0-40) and psychosocial functioning (0-8). Higher numbers indicate greater fatigue.
Measured: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
Accelerometer Tremor Assessment
The tremor will be assessed using a small accelerometer placed at the dorsal side of the wrist and above the medial tibial malleolus. Based on the changes in accelerometry a score is generated quantifying the amount of tremor during rest and movement.
Measured: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
9-Hole Peg Test
The test is a standardized, quantitative assessment used to measure finger dexterity.
Measured: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
Timed Up & Go
This test measures the time it takes patients to get up from a chair, walk 3 metres, turn around, walk 3 metres back and sit down again.
Measured: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
10 Meter Walk Test
The 10MWT assesses walking speed in meters per second over a short distance. Individuals walk 10 meters without assistance and the time is measured for the intermediate 6 meters to allow for acceleration and deceleration.
Measured: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
Freezing Of Gait Questionnaire
The FOGQ assesses Freezing of Gait (FOG) severity unrelated to falls in patients with Parkinson's Disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects (e.g., turning). Currently, FOGQ is the only validated tool available to subjectively assess FOG.
The scale has 6 items, 4 of these items are related to assess FOG severity and 2 are oriented to assess gait. Each item is assessed from 0 to 4 points. Total score ranges from 0 to 24, and higher scores correspond to more severe FOG.
Measured: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start9 Dec 2024
- Primary completion25 Jun 2026
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Randomized controlled trial with two groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- g.tec medical engineering GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690931
- Sponsor's protocol ID
- 1367/2023
- Acronym
- recoveriX PD
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32973435Sieghartsleitner 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.
PubMed 38500488Sebastian-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.
PubMed 32733182Sebastian-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.
PubMed 33192277Sebastian-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.
PubMed 37920297
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkinson's Disease Rehabilitation Using Neurofeedback With Functional Electrical Stimulation and Virtual Reality Feedback for Lower Extremities
- ClinicalTrials.gov ID
- NCT06690931
- Acronym / sponsor ID
- recoveriX PD / 1367/2023
- Conditions
- Parkinson Disease
- Keywords
- Brain-Computer Interface, Neurofeedback, EEG Feedback, Electrical Stimulation Therapy, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- g.tec medical engineering GmbHIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 motor functions in Parkinson's Disease 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 Parkinson's patients who undergo recoveriX therapy significantly improve their motor functions?
- Is the functional improvement 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, fatigue, impact of the disease in daily living activities).
Patients in the BCI group will receive 6 sessions per week during 4 weeks of BCI training with FES and VR feedback (24 sessions in total).
Patients in the control group receive 6 sessions of FES + VR therapy per week for 4 weeks (24 sessions in total). Patients in the control group will receive the same instructions as the experimental but will not wear the EEG cap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two groups
| Arm | Type | Receives |
|---|---|---|
| BCI group | Experimental | Device: Brain-Computer Interface with FES and VRPatients in the BCI group will receive 6 sessions per week during 4 weeks of BCI training with FES and VR feedback (24 sessions in total). |
| Control group | Sham comparator | Device: Motor imagery with Functional Electrical Stimulation and Virtual Reality feedbackPatients in the control group receive 6 sessions of Motor Imagery + FES + VR therapy per week for 4 weeks (24 sessions in total). Patient in the control group will receive the same instructions as the experimental group. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of PD
- HY stage between 1 to 3
- Age between 40 - 80 years old
- Ability to walk independently
- Stable medication usage
Key exclusion criteria (12 listed)
- Other neurological diseases
- Severe depression
- Uncontrolled diabetes
- Concomitant severe neurologic, cardiopulmonary, or orthopedic disorders
- Debilitating conditions or vision impairment that would impede full participation in the study.
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 |
|---|---|---|
| Brain-Computer Interface with FES and VRThe 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 24 recoveriX sessions, scheduled at 6 sessions per week, with each session lasting 1 hour. | Device | BCI group |
| Motor imagery with Functional Electrical Stimulation and Virtual Reality feedbackThe 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. | Device | Control group |
Primary outcome
Movement Disorders Society - Unified Parkinson's Disease Rating Scale Section III
Time frame: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
Motor examination.
8 secondary outcomes
Movement Disorders Society - Unified Parkinson's Disease Rating Scale - Sections I, II, IV
Time frame: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
Parkinson's Disease Questionnaire
Time frame: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
Modified Fatigue Impact Scale
Time frame: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
Accelerometer Tremor Assessment
Time frame: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
9-Hole Peg Test
Time frame: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
Timed Up & Go
Time frame: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
10 Meter Walk Test
Time frame: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
Freezing Of Gait Questionnaire
Time frame: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 32973435de 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.
- Background: PubMed 38500488Sieghartsleitner 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.
- Background: PubMed 32733182Sebastian-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.
- Background: PubMed 33192277Sebastian-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.
- Background: PubMed 37920297Sebastian-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.
- ContactLink provided by the sponsor.
- 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 Brain-Computer Interface with FES and VR and Motor imagery with Functional Electrical Stimulation and Virtual Reality feedback in people with Parkinson Disease, run by g.tec medical engineering GmbH at 1 site in Austria.
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 12 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 3 Sep 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 Austria. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Movement Disorders Society - Unified Parkinson's Disease Rating Scale Section III (time frame: All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.). 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 NCT06690931, which also lists 5 linked publications.
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 3 Sep 2026.