ARC-IM System implantation for Parkinson's (NCT06295614)
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?
- 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 5 years and 2 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?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Surgical procedure (invasive). Confirm the full schedule with the study coordinator.