Improve walking and leg function
- Trial ID
- NCT06690931
- Official Title
- Parkinson's Disease Rehabilitation Using Neurofeedback With Functional Electrical Stimulation and Virtual Reality Feedback for Lower Extremities
- Goal
- Improve walking and leg function
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- g.tec medical engineering GmbH
- Study Type
- INTERVENTIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson Disease
- Interventions
- Brain-Computer Interface with FES and VR, Motor imagery with Functional Electrical Stimulation and Virtual Reality feedback
Summary For Families
The trial aims to improve walking, balance, and lower limb function in people with Parkinson's by retraining the brain-to-muscle connection that helps you move more smoothly. It uses a brain-computer interface to detect imagined leg movements, triggers small electrical pulses to the leg muscles with functional electrical stimulation, and gives real-time virtual reality feedback so your brain practices the intended movement while the muscles actually activate. The program is a rehabilitation approach used while you stay on your usual, stable Parkinson's medications, not a drug treatment; it cannot be used by people with implanted devices like pacemakers or metal fragments that make FES unsafe. They're enrolling people aged 40 to 80 with Parkinson's at Hoehn and Yahr stages 1 to 3 who can walk independently, have stable meds and neurological status, and do not have major comorbidities, severe depression, uncontrolled diabetes, unpredictable motor fluctuations, pregnancy, or other barriers to using a BCI or FES.
Locations
- g.tec medical engineering GmbH, Schiedlberg, Upper Austria, Austria
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Brain-Computer Interface with FES and VR. The trial aims to improve walking, balance, and lower limb function in people with Parkinson's by retraining the brain-to-muscle connection that helps you move more smoothly. It uses a brain-computer interface to detect imagined leg movements, triggers small electrical pulses to the leg muscles with functional electrical stimulation, and gives real-time virtual reality feedback so your brain practices the intended movement while the muscles actually activate. The program is a rehabilitation approach used while you stay on your usual, stable Parkinson's medications, not a drug treatment; it cannot be used by people with implanted devices like pacemakers or metal fragments that make FES unsafe. They're enrolling people aged 40 to 80 with Parkinson's at Hoehn and Yahr stages 1 to 3 who can walk independently, have stable meds and neurological status, and do not have major comorbidities, severe depression, uncontrolled diabetes, unpredictable motor fluctuations, pregnancy, or other barriers to using a BCI or FES.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 8 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.