Deep Brain Stimulation management for Parkinson's (NCT02119611)
Brain stimulation improves movement control
- Trial ID
- NCT02119611
- Official Title
- Deep Brain Stimulation Therapy in Movement Disorders
- Goal
- Brain stimulation improves movement control
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study Type
- INTERVENTIONAL
- Enrollment
- 300 participants
- Conditions
- Parkinson's Disease
- Interventions
- Deep Brain Stimulation management
Summary For Families
The goal is to offer deep brain stimulation to help control troublesome movement symptoms in people with Parkinson's disease, essential tremor, or certain kinds of dystonia, and to collect clinical data on how patients do after treatment. A neurostimulator is placed in the chest and connected by thin wires to brain areas that affect movement; after surgery the device is turned on and programmed, and participants have magnetic resonance imaging and regular clinic visits so doctors can adjust settings and collect routine tests and movement and thinking assessments. Adults 18 years and older whose symptoms have not responded adequately to medication, or who already have deep brain stimulation implanted, may be eligible, provided they can undergo scans, cognitive testing, and are medically fit for surgery. Participants are followed for at least two years with scheduled visits to track symptoms, medication needs, and device programming.
Locations
- National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Deep Brain Stimulation management. The goal is to offer deep brain stimulation to help control troublesome movement symptoms in people with Parkinson's disease, essential tremor, or certain kinds of dystonia, and to collect clinical data on how patients do after treatment. A neurostimulator is placed in the chest and connected by thin wires to brain areas that affect movement; after surgery the device is turned on and programmed, and participants have magnetic resonance imaging and regular clinic visits so doctors can adjust settings and collect routine tests and movement and thinking assessments. Adults 18 years and older whose symptoms have not responded adequately to medication, or who already have deep brain stimulation implanted, may be eligible, provided they can undergo scans, cognitive testing, and are medically fit for surgery. Participants are followed for at least two years with scheduled visits to track symptoms, medication needs, and device programming.
- Who can participate?
- Participants must be between 18 Years and 100 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 16 years and 8 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.
- How many visits does this trial involve?
- You will be seen 3 4 weeks after surgery, then every month for 3 months, then every 3 months during the first year, and every 6 months during the second year; you will be followed for at least two years.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive); Injection (minimally invasive); MRI scan (non-invasive); Heart tracing (ECG) (non-invasive). Confirm the full schedule with the study coordinator.