Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611 | Recruiting

• 2 other identifiers: 14008614-N-0086
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- In deep brain stimulation (DBS), a device called a neurostimulator is placed in the chest. It is attached to wires in parts of the brain that affect movement. DBS might help people with movement disorders like Parkinson s disease (PD), dystonia, and essential tremor (ET). Objective: \- To provide DBS treatment to people with some movement disorders. Eligibility: \- Adults 18 years and older with PD, ET, or certain forms of dystonia. Design:

• Participants will be screened with medical history and physical exam. They will have blood and urine tests and:
• MRI brain scan. The participant will lie on a table that slides in and out of a metal cylinder with a magnetic field. They will be in the scanner about 60 minutes. They will get earplugs for the loud noises. During part of the MRI, a needle will guide a thin plastic tube into an arm vein and a dye will be injected.
• Electrocardiogram. Metal disks or sticky pads will be placed on the chest, arms, and legs. They record heart activity.
• Chest X-ray.
• Tests of memory, attention, concentration, thinking, and movement.
• Eligible participants will have DBS surgery. The surgery and hospital care afterward are NOT part of this protocol.
• Study doctors will see participants 3 4 weeks after surgery to turn on the neurostimulator.
• Participants will return every month for 3 months, then every 3 months during the first year, and every 6 months during the second year. Each time, participants will be examined and answer questions. DBS placement will be evaluated with MRI. The neurostimulator will be programmed. At two visits, participants will have tests of movements, thinking, and memory.

Conditions

Parkinson's Disease

Keywords

Deep Brain Stimulation; Movement Disorders; Parkinson's Disease; Essential Tremor; Tourette Syndrome

Outcome Measures

Primary Outcomes (3)

• To provide DBS therapy and follow-up management

  a. Severity of PD motor symptoms (measured by the UPDRS III scale) b. Changes in dystonia severity (measured by the Burke-Fahn-Marsden (BFM) dystonia rating scale (Burke et al., 1985) c. Changes in tremor severity (measured by the Tremor Rating Scale (TRS)) d. Levels of effective drug therapy for PD patients using the Levodopa Equivalent Drug Dosing (LEDD) e. Changes in behavior, performance of activities of daily living and complications of therapy as measured by the UPDRS I, II, and IV scales 2. To evaluate effects of DBS before and 1 year after surgery on quality of life: a. For PD patients (measured by UPDRS part II and other scales such as the PDQ-39) b. For the Dystonia and ET patients (measured by the SF-12 scale) 3. To evaluate radiographic correlation of DBS electrode position and clinical changes 4. To evaluate neurophysiological mechanisms of DBS and relevant basal ganglia physiology

  two years

• To maintain a cohort of patients treated with DBS who can participate in other NIH protocols addressing the efficacy of functional surgery and the relevant physiology

  To potentially enroll subjects in other NIH studies.

  ongoing

• Data collection

  All the data collected will be an outcome of standard of care and all analyses will be retrospective

  ongoing

Secondary Outcomes (3)

• To access other clinical outcome measures related to response to therapy

  2 years

• To correlate radiographic data related to DBS electrode position with clinical changes

  2 years

• To collect physiology data correlated with motor and cognitive function in these

  2 years

Study Arms (1)

Single-arm

OTHER

Therapy

Device: Deep Brain Stimulation management

Interventions

Deep Brain Stimulation management DEVICE

The DBS surgery will be performed according to standard of care in the centers of referral. If performed at the NIH, this will be done under protocol 11-N-0211 or other protocols permitting DBS surgery depending on future availability.

Single-arm

Eligibility Criteria

• Age: 18 Years - 100 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 comply with study procedures and provide informed consent.
• Have a clinical diagnosis of idiopathic PD, primary dystonia, or ET:
• The diagnosis of idiopathic PD will be based on the UK Brain Bank Criteria, and confirmed by the Movement Disorders Neurologists in the NIH Parkinson Clinic.
• The diagnosis of primary (generalized or segmental), hemidystonia, or cervical dystonia will be confirmed on clinical examination in the NIH Movement Disorders Clinic.
• The diagnosis of ET will be confirmed on clinical examination in the NIH Movement Disorders Clinic (the diagnosis of ET will be based on bilateral, largely symmetric postural or kinetic tremor involving hands and forearms that is visible and persistent. Additional or isolated tremor in head may be present but there should be the absence of abnormal posturing).
• a. History of appropriate response to dopaminergic medication, with at least a 30% improvement in motor UPDRS with L-DOPA by history or in-clinic testing, for the PD patients. OR
• b.Patients with tremor-dominant PD that do not respond to dopaminergic therapy and that exhibit a tremor score of at least 2 for tremor severity on at least one side of the body on the motor UPDRS examination.
• Unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of drugs), including:
• For PD patients:
• good benefit from dopaminergic medication but associated with insufficient duration of action or unacceptable side-effects OR
• intractable disabling motor fluctuations (severe off periods, dyskinesias, or freezing spells) OR
• For ET and dystonia:
• intractable symptoms of ET or dystonia impacting at least 2 activities of daily living.

You may not qualify if:

• For those who have not had DBS:
• Candidates will be excluded if they meet any of the following criteria:
• Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications, including but not limited to uncontrolled systemic hypertension with values above 170/100; unstable heart disease; unstable respiratory disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted;
• Evidence of secondary or atypical parkinsonism/dystonia/tremor as suggested by:
• History of stroke, exposure to toxins, neuroleptics, or encephalitis
• Neurologic signs of upper motor neuron or cerebellar involvement, supranuclear gaze palsy, or multiple systems atrophy.
• MR-imaging with evidence indicative of secondary disease such as tumor, or stroke, which could cause the movement disorder.
• Dementia as evidenced by formal neuropsychological evaluation, Mattis Dementia Rating Scale (DRS-2) score, and clinical evaluations.
• Unable to complete cognitive assessments and testing necessary to adequately evaluate risks and benefits of surgery.
• Clinically signficiant or unstable psychiatric disorder such as severe depression or anxiety, which, in the opinion of the investigators would increase the risk of developing postoperative complications.
• Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small closed spaces (have claustrophobia), or cannot lie comfortably on their back for up to one hour.
• Pregnant women.
• Otherwise not eligible for DBS surgery, for example known inability to undergo anesthesia
• For those who have had DBS:
• Contra-indications for ongoing stimulation, such as intractable side effects of DBS despite stimulation parameter adjustment

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 Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders; Essential Tremor; Tourette Syndrome

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Tic Disorders; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Debra J Ehrlich, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene H Dustin, C.R.N.P.

CONTACT

(301) 402-4479; irene.dustin@nih.gov

Debra J Ehrlich, M.D.

CONTACT

(301) 443-7888; debra.ehrlich@nih.gov

Study Design

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

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: April 2, 2014
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-03-23

Locations

US (1)