Neurofeedback rehabilitation for Parkinson's disease using virtual reality and electrical stimulation
Parkinson's Disease Rehabilitation Using Neurofeedback With Functional Electrical Stimulation and Virtual Reality Feedback for Lower Extremities
This study is testing a new virtual reality and electrical stimulation system to see if it can help people with Parkinson's disease improve their movement better than regular treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | g.tec medical engineering GmbH Industry-sponsored |
| Locations | 1 site (Schiedlberg, Upper Austria) |
| Trial ID | NCT06690931 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of the recoveriX PRO system, a Brain-Computer Interface (BCI) that integrates Motor Imagination (MI) with Functional Electrical Stimulation (FES) and Virtual Reality (VR) for patients with Parkinson's Disease. Participants will wear an EEG cap to monitor neural activity while they engage in motor tasks, allowing them to control FES and VR feedback. The study aims to compare the outcomes of this BCI-based treatment against standard therapies that do not utilize EEG monitoring. Researchers will assess improvements in motor functions and determine if the BCI approach offers superior benefits.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 to 80 with a diagnosis of Parkinson's Disease who can walk independently and have stable medication usage.
Not a fit: Patients with other neurological diseases, severe depression, or those with implanted medical devices that restrict the use of FES may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance motor function recovery in patients with Parkinson's Disease.
How similar studies have performed: While the use of BCI in rehabilitation is gaining interest, this specific combination of BCI with FES and VR for Parkinson's Disease is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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.
Where this trial is running
Schiedlberg, Upper Austria
- g.tec medical engineering GmbH — Schiedlberg, Upper Austria, Austria (Recruiting)
Study contacts
- Study coordinator: Rupert Ortner, PhD
- Email: ortner@gtec.at
- Phone: +43725122240
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.