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Tests deep brain stimulation in adults with movement disorders

Tests a brain implant device that is placed in adults with Parkinson's disease.

Key facts

Who runs it
National Institute of Neurological Disorders and Stroke (NINDS)
Where
Bethesda, United StatesSee the site
Trial code
Registry title
Deep Brain Stimulation Therapy in Movement Disorders
Status
Recruiting
People taking part
300 people, planned
Started
2 Apr 2014
Expected to end
1 Dec 2030
Type of study
Interventional
Treatments tested
  • Deep Brain Stimulation management
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Parkinson's disease, primary dystonia or essential tremor (ET) whose symptoms are not controlled well by medicines. People must be interested in deep brain stimulation (DBS), or already have a DBS device.

Age
18 Years to 100 Years
Sex
All sexes can join.
Disease stage
Idiopathic Parkinson's disease (by UK Brain Bank Criteria), primary generalized or segmental dystonia, hemidystonia, cervical dystonia, or ET in both hands and forearms. Symptoms are hard to control. For ET or dystonia, symptoms affect at least 2 daily activities.
Earlier treatment
People must have tried the fullest medicine treatment, with higher and lower doses, without enough benefit. In Parkinson's, medicine helped too briefly, caused side effects, or severe off periods, dyskinesias or freezing remain. People who already have DBS, also placed outside the NIH, can join.
Biomarker or test result
Parkinson's: at least a 30% improvement in motor UPDRS with L-DOPA. Or tremor-dominant Parkinson's not helped by dopaminergic therapy, with a tremor score of at least 2 on one side or more.

Main reasons for not taking part

  • Serious medical illness raising surgery risk, such as blood pressure above 170/100, unstable heart or lung disease, or blood thinners that cannot be stopped.
  • Movement problems caused by something else, such as stroke, toxins, neuroleptics, encephalitis, tumor or atypical parkinsonism.
  • Dementia, or unable to complete thinking tests.
  • Serious or unstable mental illness, such as severe depression or anxiety, or unable to have an MRI scan.
  • Pregnant women, or people who cannot have anesthesia.

The registry criteria, word for word

Show all 19 criteriaShow less

Who cannot take part

  • Unable to complete cognitive assessments and testing necessary to adequately evaluate risks and benefits of surgery
  • 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
  • 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
  • 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
  • For those who have not had DBS:
  • Candidates will be excluded if they meet any of the following criteria:
  • Pregnant women

Other 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 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; Interested in being evaluated to undergo DBS, if indicated, to treat medically refractory movement disorder or; Patients already implanted with DBS for continued management; (Note: Inclusion criteria 4 and 5 can be met by historical report in patients who had DBS implanted outside the NIH)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 100 years old?

Where in United States

  • National Institutes of Health Clinical CenterBethesda, United StatesContact: Irene H Dustin, C.R.N.P.Taking people

About the trial

What the trial wants to find out

Background:

Read full original descriptionShow less

- 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....

The group in the trial

  • Single-armOther group

    Therapy

    Treatment: Deep Brain Stimulation management

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Deep Brain Stimulation Therapy in Movement Disorders
Plain-language title
Tests deep brain stimulation in adults with movement disordersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT02119611, who can take part
Record updated
12 November 2026