Deep Brain Stimulation Surgery for Movement Disorders

NCT01581580 | Recruiting FDA Device

• 2 other identifiers: 11021111-N-0211
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease; Essential Tremor; Dystonia

Keywords

Parkinson's Disease; Deep Brain Stimulation; Neurophysiology; Movement Disorder; Dystonia; Parkinson Disease; Essential Tremor

Outcome Measures

Primary Outcomes (1)

• physiology and efficacy of DBS surgery for movement disorders

  change in UPDRS III scale, Burke-Fahn-Marsden (BFM) scale, and Tremor Rating Scale

  3 months

Study Arms (1)

treatment arm

OTHER

patients with Parkinson's Disease, dysonia, and essential tremor

Device: Medtronic Activa Tremor Control System; Procedure: Deep Brain Stimulation

Interventions

Medtronic Activa Tremor Control System DEVICE

Medtronic DBS Therapy delivers electrical stimulation to an area in the brain to help treat Parkinson's Disease, dystonia, and essential tremor.

treatment arm

Deep Brain Stimulation PROCEDURE

standard of care DBS surgery for patients with Parkinson's Disease, dystonia, and essential tremor

treatment arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Candidates will be excluded if they:
• Are unable or unwilling to give informed consent to the research procedures.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

• de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol. 2006 Jun;5(6):525-35. doi: 10.1016/S1474-4422(06)70471-9.

  PMID: 16713924 BACKGROUND

• DeLong MR. Primate models of movement disorders of basal ganglia origin. Trends Neurosci. 1990 Jul;13(7):281-5. doi: 10.1016/0166-2236(90)90110-v.

  PMID: 1695404 BACKGROUND

• Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71. doi: 10.1016/0166-2236(90)90107-l.

  PMID: 1695401 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor; Dystonia; Movement Disorders

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Kareem A Zaghloul, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon C Park

CONTACT

(301) 496-2921; sharon.park@nih.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 20, 2012
• Study Start: August 17, 2011
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 24, 2026

Record last verified: 2025-07-18

Locations

US (1)