Deep Brain Stimulation Therapy in Movement Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT02119611
First received: April 16, 2014
Last updated: May 13, 2014
Last verified: March 2014
  Purpose

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.

Condition Intervention
Parkinson's Disease
Movement Disorders
Deep Brain Stimulation
Dystonia
Essential Tremor
Other: Deep Brain Stimulation Management

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Deep Brain Stimulation Therapy in Movement Disorders

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To train NINDS Medical Neurology Branch and Parkinson Clinic fellows in the method of DBS surgery and subsequent stimulator management in the treatment of medically refractory PD, dystonia, ET. [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: March 2014
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Deep Brain Stimulation Management
    Therapy
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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 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.
  • 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:

  • Age 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;
  • Cognitive impairment on Full Scale Intelligence Quotient (FSIQ) portion of Wechsler Adult Intelligence test (FSIQ less than 70).
  • 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 and Mattis Dementia Rating Scale-2 (DRS-2) score below 128.
  • 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:

Contra-indications for ongoing stimulation, such as intractable side effects of DBS despite stimulation parameter adjustment

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02119611

Contacts
Contact: Beverly A McElroy, R.N. (301) 402-4479 mcelroyb@ninds.nih.gov
Contact: Codrin I Lungu, M.D. (301) 402-0976 lunguci@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Codrin I Lungu, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT02119611     History of Changes
Other Study ID Numbers: 140086, 14-N-0086
Study First Received: April 16, 2014
Last Updated: May 13, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Deep Brain Stimulation
Movement Disorders
Parkinson's Disease
Dystonia
Essential Tremor

Additional relevant MeSH terms:
Essential Tremor
Disease
Dystonia
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Dyskinesias
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Parkinsonian Disorders
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014