Brain stimulation reduces disabling tremor
- Trial ID
- NCT02119611
- Official Title
- Deep Brain Stimulation Therapy in Movement Disorders
- Goal
- Brain stimulation reduces disabling tremor
- 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 aim is to help people whose Parkinson's symptoms are not adequately controlled by medicines, especially disabling tremor, severe off periods, motor fluctuations, or dyskinesias that limit daily life. It uses deep brain stimulation, an implanted neurostimulator that delivers targeted electrical pulses to brain areas such as the subthalamic nucleus, globus pallidus, or thalamus to calm abnormal motor circuits, which can reduce tremor, slowness and involuntary movements, smooth out on/off swings and often allow lower or more stable levodopa dosing. Adults 18 to 100 with idiopathic PD, essential tremor, or primary dystonia who have had inadequate benefit from maximal medical therapy are eligible, with PD patients needing a history of meaningful levodopa response or tremor-dominant disease not helped by meds; people with major medical, cognitive, psychiatric, MRI incompatibilities, pregnancy, or other contraindications to DBS are excluded, and those already implanted with DBS may also enroll.
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 aim is to help people whose Parkinson's symptoms are not adequately controlled by medicines, especially disabling tremor, severe off periods, motor fluctuations, or dyskinesias that limit daily life. It uses deep brain stimulation, an implanted neurostimulator that delivers targeted electrical pulses to brain areas such as the subthalamic nucleus, globus pallidus, or thalamus to calm abnormal motor circuits, which can reduce tremor, slowness and involuntary movements, smooth out on/off swings and often allow lower or more stable levodopa dosing. Adults 18 to 100 with idiopathic PD, essential tremor, or primary dystonia who have had inadequate benefit from maximal medical therapy are eligible, with PD patients needing a history of meaningful levodopa response or tremor-dominant disease not helped by meds; people with major medical, cognitive, psychiatric, MRI incompatibilities, pregnancy, or other contraindications to DBS are excluded, and those already implanted with DBS may also enroll.
- 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?
- 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 16 years and 8 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.