Brain stimulation reduces movement fluctuations
- Trial ID
- NCT01682668
- Official Title
- Role of the Subthalamic Nucleus in the Control of Movement: Physiopathology of Akinesia in Parkinson's Disease.
- Goal
- Brain stimulation reduces movement fluctuations
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Study Type
- INTERVENTIONAL
- Enrollment
- 180 participants
- Conditions
- Parkinson's Disease
- Interventions
- Bilateral subthalamic stimulation
Summary For Families
Goal: Learn how the subthalamic nucleus drives akinesia and other movement problems in Parkinson's, and whether targeting it can reduce motor fluctuations, dyskinesias, and gait or balance issues. Approach: Bilateral deep brain stimulation of the subthalamic nucleus uses implanted electrodes to send continuous electrical pulses that normalize abnormal basal ganglia firing, improving movement and often allowing lower levodopa doses. Eligibility: Adults 18 to 70 with idiopathic Parkinson's are sought, including surgical candidates with motor complications and excellent levodopa responsiveness (greater than 50% improvement on testing), plus separate groups of non-operated and already-operated patients; people with dementia, unstable psychiatric illness, MRI contraindications, or other surgical risks are excluded.
Locations
- CIC-GHPS, Paris, France
- Groupe Hospitalier Pitie-Salpêtrière, Paris, France
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Bilateral subthalamic stimulation. Goal: Learn how the subthalamic nucleus drives akinesia and other movement problems in Parkinson's, and whether targeting it can reduce motor fluctuations, dyskinesias, and gait or balance issues. Approach: Bilateral deep brain stimulation of the subthalamic nucleus uses implanted electrodes to send continuous electrical pulses that normalize abnormal basal ganglia firing, improving movement and often allowing lower levodopa doses. Eligibility: Adults 18 to 70 with idiopathic Parkinson's are sought, including surgical candidates with motor complications and excellent levodopa responsiveness (greater than 50% improvement on testing), plus separate groups of non-operated and already-operated patients; people with dementia, unstable psychiatric illness, MRI contraindications, or other surgical risks are excluded.
- Who can participate?
- Participants must be between 18 Years and 70 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- 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 12 years and 3 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.