Reduce tremor and involuntary movements
- Trial ID
- NCT05626608
- Official Title
- Neuromodulation électrique Continue du Globus Pallidus Dans la Maladie de Parkinson Par l'électrode Directionnelle CARTESIA™
- Goal
- Reduce tremor and involuntary movements
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University Hospital, Montpellier
- Study Type
- INTERVENTIONAL
- Enrollment
- 10 participants
- Conditions
- Parkinson Disease
- Interventions
- Classical ring stimulation, Stimulation in directional mode
Plain-Language Summary
Aimed at cutting down disabling tremor and major motor fluctuations or dyskinesias in people with Parkinson's who still respond to levodopa. It compares conventional ring deep brain stimulation to directional stimulation using the CARTESIA™ electrode in the globus pallidus; directional mode steers current toward problem areas to boost symptom control and reduce stimulation side effects, and DBS generally works alongside levodopa and can allow lower medication doses. Looking for adults 18 to 70 with bilateral idiopathic PD for several years, a clear levodopa response (about 30% improvement), significant motor symptoms despite meds, an off‑med UPDRS III score over 25, and who are candidates for bilateral DBS surgery. People with dementia, severe psychiatric illness, MRI or anesthesia contraindications, pregnancy, inability to complete long follow up, or without informed consent are excluded.
Locations
- Centre Hospitalier Uniersitaire de Montpellier, Montpellier, France, France
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Classical ring stimulation. Aimed at cutting down disabling tremor and major motor fluctuations or dyskinesias in people with Parkinson's who still respond to levodopa. It compares conventional ring deep brain stimulation to directional stimulation using the CARTESIA™ electrode in the globus pallidus; directional mode steers current toward problem areas to boost symptom control and reduce stimulation side effects, and DBS generally works alongside levodopa and can allow lower medication doses. Looking for adults 18 to 70 with bilateral idiopathic PD for several years, a clear levodopa response (about 30% improvement), significant motor symptoms despite meds, an off‑med UPDRS III score over 25, and who are candidates for bilateral DBS surgery. People with dementia, severe psychiatric illness, MRI or anesthesia contraindications, pregnancy, inability to complete long follow up, or without informed consent are excluded.
- Who can participate?
- Participants must be between 18 Years and 70 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 3 years and 6 months.