Alleviate gait freezing and instability
- Trial ID
- NCT06295614
- Official Title
- Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease
- Goal
- Alleviate gait freezing and instability
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Study Type
- INTERVENTIONAL
- Enrollment
- 6 participants
- Conditions
- Parkinson Disease
- Interventions
- ARC-IM System implantation
Summary For Families
The goal is to ease severe walking problems in Parkinson's, especially postural instability and freezing of gait, for people who still struggle despite optimal medications. The approach implants the ARC-IM system, a small device that delivers targeted electrical stimulation to the neural circuits that control walking, aiming to improve step initiation, balance, and steadier gait while working alongside levodopa rather than replacing it. The study is enrolling adults 18 and older with typical Parkinson's at Hoehn-Yahr stage II to IV who have persistent gait impairments despite best medical management, can communicate in French or English, and are willing to undergo the implant and follow-up visits. People with atypical Parkinsonism, unstable medical or psychiatric conditions, planned major PD surgeries like DBS, pregnancy, frequent MRI needs, recent substance abuse, or recent experimental treatments are excluded.
Locations
- Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Canton of Vaud, Switzerland
Frequently Asked Questions
- What is this trial testing?
- This trial is studying ARC-IM System implantation. The goal is to ease severe walking problems in Parkinson's, especially postural instability and freezing of gait, for people who still struggle despite optimal medications. The approach implants the ARC-IM system, a small device that delivers targeted electrical stimulation to the neural circuits that control walking, aiming to improve step initiation, balance, and steadier gait while working alongside levodopa rather than replacing it. The study is enrolling adults 18 and older with typical Parkinson's at Hoehn-Yahr stage II to IV who have persistent gait impairments despite best medical management, can communicate in French or English, and are willing to undergo the implant and follow-up visits. People with atypical Parkinsonism, unstable medical or psychiatric conditions, planned major PD surgeries like DBS, pregnancy, frequent MRI needs, recent substance abuse, or recent experimental treatments are excluded.
- Who can participate?
- Participants must be at least 18 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 5 years and 2 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.