Recruiting · registry statusStudying brain stimulation surgery for movement disorders
Researchers are studying surgery to implant a device that stimulates movement-related brain areas in people whose symptoms need further treatment.
Testing a treatment or activity · Study reference: NCT01581580
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
Open the official registry record ↗Who can join?
Ages 18 years to 99 years · Does not accept healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
* INCLUSION CRITERIA:
To be eligible for entry into the study, candidates must meet all the following criteria:
Be 18 years of age or older.
Able to provide informed consent.
Have a clinical diagnosis of one of the following as confirmed by the NIH movement disorders clinic team and the multi-disciplinary DBS surgical conference, and deemed as appropriate for the use of Deep Brain Stimulation therapy:
* idiopathic PD not adequately controlled with medication or
* primary dystonia that is medically refractory, or
* ET that is not adequately controlled by medications or constitutes a significant functional disability.
EXCLUSION CRITERIA:
Candidates will be excluded if they:
Are unable or unwilling to give informed consent to the research procedures.
Full study name & original research details
Official study title
Deep Brain Stimulation Surgery for Movement Disorders
Original description
Background:
\- Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest. It is used to stimulate the areas of the brain that affect movement. Stimulating these areas helps to block the nerve signals that cause abnormal movements. Researchers also want to record the brain function of people with movement disorders during the surgery.
Objectives:
* To study how DBS surgery affects Parkinson s disease, dystonia, and tremor.
* To obtain information on brain and nerve cell function during DBS surgery.
Eligibility:
\- People at least 18 years of age who have movement disorders, like Parkinson's disease, essential tremor, and dystonia.
Design:
* Researchers will screen patients with physical and neurological exams to decide whether they can have the surgery. Patients will also have a medical history, blood tests, imaging studies, and other tests. Before the surgery, participants will practice movement and memory tests.
* During surgery, the stimulator will be placed to provide the right amount of stimulation for the brain. Patients will perform the movement and memory tests that they practiced earlier.
* After surgery, participants will recover in the hospital. They will have a followup visit within 4 weeks to turn on and adjust the stimulator. The stimulator has to be programmed and adjusted over weeks to months to find the best settings.
* Participants will return for followup visits at 1, 2, and 3 months after surgery. Researchers will test their movement, memory, and general quality of life. Each visit will last about 2 hours.
Further description from the registry
Objective:
The objective of this protocol is to collect prospective physiology data related to DBS therapy and motor and cognitive function in people with medically refractory Parkinson's disease (PD), dystonia, and essential tremor (ET). All treatment under this protocol will be based on the current standard of care for DBS surgery.
Study Population:
Patients 18 years and older with medically refractory PD, dystonia and/or ET may participate in this study.
Study Design:
The treatment that is rendered in this protocol is standard of care for PD, dystonia, and ET. Patients confirmed to have medically refractory PD, dystonia or ET will be offered DBS. The therapeutic goal of this procedure is to implant chronically stimulating macroelectrodes in the basal ganglia or thalamic nuclei in order to alleviate the symptoms of PD, dystonia or ET. Pre- and post-operative imaging will be used to precisely localize electrode locations within the brain and will be correlated with measures of clinical efficacy and recorded intra-operative neural activity. Intra-operative microelectrode recordings, as well as micro- and macroelectrode electrical stimulation, will be used to confirm positioning of electrode leads. Intra-operative electrode recordings will also be used to investigate the neurophysiological mechanisms of deep brain stimulation and to explore the neural circuits underlying motor and cognitive processing in the basal ganglia. Intraoperative physiology will be used for clinical and research purposes. Patients will be followed for 3 months after the surgical procedure to determine effectiveness of DBS treatment.
Outcome Measures:
The primary goal of this protocol is to characterize motor and cognitive function in people receiving standard of care DBS surgery for movement disorders. Secondary measures include 1) radiographic correlation of DBS electrode position and clinical changes; and 2) neurophysiological mechanisms of DBS and motor and cognitive function in the basal ganglia.
Conditions reported: Parkinson's Disease; Essential Tremor; Dystonia
- Study type
- Interventional
- Interventions
- Medtronic Activa Tremor Control System; Deep Brain Stimulation
- Phases
- NA
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Start date reported by registry
- 2011-08-17 (actual)
Registry updated: 2026-10-08 · Status last verified by the registry submitter: 2026-06-02
Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Sharon C Park · (301) 496-2921 · sharon.park@nih.gov
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
RecruitingFor more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · 800-411-1222 · ccopr@nih.gov
The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.