Medtronic Activa Tremor Control Sy… for Parkinson's (NCT01581580)
Reduce tremor using Medtronic Activa
- Trial ID
- NCT01581580
- Official Title
- Deep Brain Stimulation Surgery for Movement Disorders
- Goal
- Reduce tremor using Medtronic Activa
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study Type
- INTERVENTIONAL
- Enrollment
- 200 participants
- Conditions
- Parkinson's Disease, Essential Tremor, Dystonia
- Interventions
- Medtronic Activa Tremor Control System, Deep Brain Stimulation
Summary For Families
The goal is to reduce disabling movement problems like tremor, stiffness, slowness, or dystonic postures when medications are not controlling symptoms. It uses the Medtronic Activa Tremor Control System, a surgically implanted deep brain stimulation device that delivers continuous electrical pulses to targeted brain regions to quiet abnormal circuits that cause tremor and other motor issues, often improving symptoms and allowing lower levodopa doses or fewer on/off swings. To join, you must be 18 to 99, able to give informed consent, and have a diagnosis confirmed by the NIH movement disorders team of idiopathic Parkinson's not adequately controlled by meds, primary dystonia refractory to treatment, or essential tremor causing significant disability despite medication. People who cannot or will not give informed consent are excluded.
Locations
- National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Medtronic Activa Tremor Control System. The goal is to reduce disabling movement problems like tremor, stiffness, slowness, or dystonic postures when medications are not controlling symptoms. It uses the Medtronic Activa Tremor Control System, a surgically implanted deep brain stimulation device that delivers continuous electrical pulses to targeted brain regions to quiet abnormal circuits that cause tremor and other motor issues, often improving symptoms and allowing lower levodopa doses or fewer on/off swings. To join, you must be 18 to 99, able to give informed consent, and have a diagnosis confirmed by the NIH movement disorders team of idiopathic Parkinson's not adequately controlled by meds, primary dystonia refractory to treatment, or essential tremor causing significant disability despite medication. People who cannot or will not give informed consent are excluded.
- Who can participate?
- Participants must be between 18 Years and 99 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 18 years and 3 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?
- Participants will return for followup visits at 1, 2, and 3 months after surgery, and each visit will last about 2 hours.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive); Blood draw (minimally invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.