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
Plain-Language Summary
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.