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?
- 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 18 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.