Bilateral subthalamic stimulation for Parkinson's (NCT01682668)
Improve slowed movement with stimulation
- Trial ID
- NCT01682668
- Official Title
- Role of the Subthalamic Nucleus in the Control of Movement: Physiopathology of Akinesia in Parkinson's Disease.
- Goal
- Improve slowed movement with stimulation
- 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: to learn how a small deep brain area called the subthalamic nucleus helps control movement, how problems there cause slowed or reduced movement in Parkinson's, and why stimulating it can improve movement symptoms. Approach: researchers apply electrical stimulation to that area on both sides of the brain and compare people with Parkinson's (before and after surgery), people already treated with bilateral stimulation, and healthy volunteers to see how movement and control change. Eligibility: adults 18 to 70, including people with Parkinson's who have movement fluctuations or involuntary movements despite treatment and who respond well to levodopa on testing, people already living with bilateral stimulation for over a year, and healthy volunteers, with exclusions for dementia, unstable psychiatric or medical conditions, and any reason that prevents magnetic resonance imaging or safe surgery.
Locations
- Groupe Hospitalier Pitie-Salpêtrière, Paris, PARIS, France
- CIC-GHPS, Paris, France
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Bilateral subthalamic stimulation. Goal: to learn how a small deep brain area called the subthalamic nucleus helps control movement, how problems there cause slowed or reduced movement in Parkinson's, and why stimulating it can improve movement symptoms. Approach: researchers apply electrical stimulation to that area on both sides of the brain and compare people with Parkinson's (before and after surgery), people already treated with bilateral stimulation, and healthy volunteers to see how movement and control change. Eligibility: adults 18 to 70, including people with Parkinson's who have movement fluctuations or involuntary movements despite treatment and who respond well to levodopa on testing, people already living with bilateral stimulation for over a year, and healthy volunteers, with exclusions for dementia, unstable psychiatric or medical conditions, and any reason that prevents magnetic resonance imaging or safe surgery.
- 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?
- 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 13 years and 5 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?
- Everyone in this trial receives the experimental treatment. There is no placebo group.