Improve balance using neurofeedback exergaming
- Trial ID
- NCT05986643
- Official Title
- Using Biofeedback During Exergaming to Attenuate Alpha Oscillations to Improve Postural Control in People Living With Parkinson's.
- Goal
- Improve balance using neurofeedback exergaming
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Leicester
- Study Type
- INTERVENTIONAL
- Enrollment
- 100 participants
- Conditions
- Parkinson Disease
- Interventions
- Exergame+Neurofeedback, Exergame [alone]
Summary For Families
The goal is to improve postural control and reduce falls and freezing of gait, which are common and disabling problems in Parkinson's. The approach pairs balance-focused exergaming with real-time neurofeedback so people can see and learn to reduce alpha brain wave oscillations linked to attention and balance, with the hope that lowering those oscillations during movement will strengthen automatic postural responses. The study is looking for adults with mild-to-moderate Parkinson's who can stand and walk unaided (Hoehn and Yahr ≤4), who exercise less than recommended, have had at least one fall and one freezing episode in the past year, and are either on a stable dose of dopaminergic medication or untreated and not expected to start meds in the next three months; people with deep brain stimulators or other head metal implants, dementia, severe mobility limits, major medical issues that make exercise unsafe, or who need a walking aid are excluded.
Locations
- University of Leicester, Leicester, United Kingdom
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Exergame+Neurofeedback. The goal is to improve postural control and reduce falls and freezing of gait, which are common and disabling problems in Parkinson's. The approach pairs balance-focused exergaming with real-time neurofeedback so people can see and learn to reduce alpha brain wave oscillations linked to attention and balance, with the hope that lowering those oscillations during movement will strengthen automatic postural responses. The study is looking for adults with mild-to-moderate Parkinson's who can stand and walk unaided (Hoehn and Yahr ≤4), who exercise less than recommended, have had at least one fall and one freezing episode in the past year, and are either on a stable dose of dopaminergic medication or untreated and not expected to start meds in the next three months; people with deep brain stimulators or other head metal implants, dementia, severe mobility limits, major medical issues that make exercise unsafe, or who need a walking aid are excluded.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- 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 3 years and 4 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.