Brain-Computer Interface with FES… for Parkinson's (NCT06690931)
Brain controlled training improves walking
- Trial ID
- NCT06690931
- Official Title
- Parkinson's Disease Rehabilitation Using Neurofeedback With Functional Electrical Stimulation and Virtual Reality Feedback for Lower Extremities
- Goal
- Brain controlled training improves walking
- 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
Goal: to see whether a brain-computer interface therapy can safely improve movement in people with Parkinson's and whether it works better than the same mental-practice therapy without monitoring brain activity. Approach: participants wear an electroencephalography cap that reads brain signals while they imagine moving, and those signals control electrical stimulation to the leg muscles plus virtual reality feedback so the person can see and feel the imagined movement. Both groups get 24 sessions over 4 weeks (six sessions per week); the comparison group gets the same mental practice with electrical stimulation and virtual reality but does not wear the brain-cap. Eligibility: adults 40 to 80 years old with early to mid-stage Parkinson's (stages 1 to 3) who can walk independently and have stable medication and neurologic status.
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. Goal: to see whether a brain-computer interface therapy can safely improve movement in people with Parkinson's and whether it works better than the same mental-practice therapy without monitoring brain activity. Approach: participants wear an electroencephalography cap that reads brain signals while they imagine moving, and those signals control electrical stimulation to the leg muscles plus virtual reality feedback so the person can see and feel the imagined movement. Both groups get 24 sessions over 4 weeks (six sessions per week); the comparison group gets the same mental practice with electrical stimulation and virtual reality but does not wear the brain-cap. Eligibility: adults 40 to 80 years old with early to mid-stage Parkinson's (stages 1 to 3) who can walk independently and have stable medication and neurologic status.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 8 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- Both the BCI and control groups will receive 6 sessions per week for 4 weeks (24 sessions in total).
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain wave recording (EEG) (non-invasive). Confirm the full schedule with the study coordinator.