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?
- 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.
- 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.