Classical ring stimulation for Parkinson's (NCT05626608)
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
Summary For Families
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?
- 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 3 years and 6 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?
- This is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. Ask the coordinator for the exact sequence and how long each phase lasts.
- How many visits does this trial involve?
- The study requires regular follow-up for at least 30 months.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.