NCT06690931Completed
Neurofeedback Rehabilitation With FES and VR for PD
Parkinson's Disease Rehabilitation Using Neurofeedback With Functional Electrical Stimulation and Virtual Reality Feedback for Lower Extremities
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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: 1. Will Parkinson's patients who undergo recoveriX therapy significantly improve their motor functions? 2. Is the functional improvement achieved with the BCI treatment superior to the standard MI+FES+VR treatment? 3. 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 14 Nov 2024
- Start date
- 9 Dec 2024
- Primary completion date
- 25 Jun 2026
- Lead sponsor
- g.tec medical engineering GmbH
- Diseases
- Parkinson disease
- NCT number
- NCT06690931
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 9 Dec 2024 to the primary completion date, 25 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant severe neurologic, cardiopulmonary, or orthopedic disorders
- Under the influence of anesthesia or similar medication.
Other illness
- Other neurological diseases
- Uncontrolled diabetes
- Debilitating conditions or vision impairment that would impede full participation in the study.
Other
- Severe depression
- Unpredictable motor fluctuations
- 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.
- With fractures or lesions in the upper and lower extremities.
- Inadequate control of a BCI system.
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| g.tec medical engineering GmbH Coordinator of this site? Confirm its status | Schiedlberg | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.