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
Plain-Language Summary
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.