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Protocol Details

Deep Brain Stimulation Therapy in Movement Disorders

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

14-N-0086

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: NA

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

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

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Other: Deep Brain Stimulation Management

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

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Eligibility

INCLUSION CRITERIA:

To be eligible for entry into the study, candidates must meet all the following criteria:

-Be 18 years of age or older.

-Can speak and understand sufficient English or Spanish to provide informed consent and complete study assessments validly.

-Able to 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).

-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

--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.

-Interested in being evaluated to undergo DBS, if indicated, to treat medically refractory movement disorder or Patients already implanted with DBS for continued management

EXCLUSION CRITERIA:

For those who have not had DBS:

Candidates will be excluded if they meet any of the following criteria:

- under 18 years

-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;

-Intellectual impairment as determined by a score of less than 70 on the estimated General Ability Index (GAI), a composite score of the Wechsler Adult Intelligence test fourth Edition (WAIS-IV) or equivalent to FSIQ less than 70, which would render the participant unable to provide informed consent or to comply with the study procedures.

-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 orthostatic hypotension.

-MR-imaging with evidence indicative of secondary disease such as iron deposits in putamen, 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 in English or Spanish.

-Depression or anxiety as evidenced by self-report on the Beck Depression Inventory- 2 (score above 20) and Beck Anxiety Inventory, respectively.

-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:

1. Contra-indications for ongoing stimula ide effects of DBS despite stimulation parameter adjustment


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Citations:

Albin RL, Young AB, Penney JB. The functional anatomy of basal ganglia disorders. Trends Neurosci. 1989 Oct;12(10):366-75.

Aziz TZ, Peggs D, Sambrook MA, Crossman AR. Lesion of the subthalamic nucleus for the alleviation of 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP)-induced parkinsonism in the primate. Mov Disord. 1991;6(4):288-92.

Baker KB, Nyenhuis JA, Hrdlicka G, Rezai AR, Tkach JA, Shellock FG. Neurostimulation systems: assessment of magnetic field interactions associated with 1.5- and 3-Tesla MR systems. J Magn Reson Imaging. 2005 Jan;21(1):72-7.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Debra J. Ehrlich, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 7D37
10 CENTER DR
BETHESDA MD 20814
(301) 443-7888
debra.ehrlich@nih.gov

Irene H. Dustin, C.R.N.P.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10-CRC RM 5-1473
10 CENTER DR
BETHESDA MD 20814
(301) 402-4479
id30d@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02119611

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