Deep Brain Stimulation Therapy in Movement Disorders
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 100 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 2 visits
- Procedures mentioned: Physical exams, Urine samples, MRI scans, Heart tracing (ECG), X-rays
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Design: * Participants will be screened with medical history and physical exam."
- "They will have blood and urine tests and: * MRI brain scan."
- "During part of the MRI, a needle will guide a thin plastic tube into an arm vein and a dye will be injected. * Electrocardiogram."
- "They record heart activity. * Chest X-ray. * Tests of memory, attention, concentration, thinking, and movement. * Eligible participants will have DBS surgery."
- "DBS placement will be evaluated with MRI."
- "At two visits, participants will have tests of movements, thinking, and memory."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study provides deep brain stimulation (DBS) care for adults with Parkinson’s disease, essential tremor, or certain types of dystonia. DBS uses a device in the chest connected to wires in the brain to help control movement. The study includes device adjustments and follow-up care, but DBS surgery and the hospital stay are not part of this study.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Be able to follow study steps and give informed consent, meaning you understand and agree to join.
- Have a diagnosis confirmed by NIH specialists: Parkinson’s disease with no known cause, essential tremor (ongoing shaking), or an allowed type of dystonia (muscle tightening that causes twisting or unusual positions).
- For Parkinson’s: movement symptoms improved by at least 30% with L-DOPA medicine, or shaking is the main symptom, does not respond to medicine, and meets the study’s severity score.
- For Parkinson’s: medicines do not give enough lasting relief, cause unacceptable side effects, or leave severe movement problems.
- For essential tremor or dystonia: symptoms remain hard to control with medicines and affect at least two daily activities.
- Want to be checked for DBS surgery, or already have a DBS device and need ongoing care. People who had DBS outside NIH may use past medical history to show medicine response and treatment problems.
Who can't join
- If you already have DBS: cannot safely continue stimulation, such as side effects that do not improve after device adjustments.
- If you have not had DBS: have a health problem that raises surgery risks, such as uncontrolled blood pressure above 170/100, unstable heart or breathing disease, or blood-clotting problems.
- If you have not had DBS: have an unusual form of the movement disorder or one linked to another cause, such as a stroke, tumor, certain drugs, or toxins.
- If you have not had DBS: have dementia, which affects memory and thinking, or cannot complete the thinking tests needed to judge surgery risks.
- If you have not had DBS: have a serious or unstable mental health condition that raises surgery risks.
- If you have not had DBS: cannot have an MRI scan because of certain implants or metal, fear of small spaces, or trouble lying on your back for up to one hour.
- If you have not had DBS: are pregnant.
- If you have not had DBS: cannot safely have DBS surgery for another reason, such as being unable to receive anesthesia.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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: 1. 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. 2. The diagnosis of primary (generalized or segmental), hemidystonia, or cervical dystonia will be confirmed on clinical examination in the NIH Movement Disorders Clinic. 3. 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: 1. good benefit from dopaminergic medication but associated with insufficient duration of action or unacceptable side-effects OR 2. intractable disabling motor fluctuations (severe off periods, dyskinesias, or freezing spells) OR For ET and dystonia: 3. 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) EXCLUSION CRITERIA: 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: 1. History of stroke, exposure to toxins, neuroleptics, or encephalitis 2. Neurologic signs of upper motor neuron or cerebellar involvement, supranuclear gaze palsy, or multiple systems atrophy. 3. 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
Study sites (1)
MD
- National Institutes of Health Clinical Center · Bethesda, MD 20892For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Study contact · 800-411-1222 ext. TTY dial 711 · ccopr@nih.govMore trials in Bethesda