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Deep Brain Stimulation Surgery for 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 99 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

  • Time periods mentioned: 3 months
  • Procedures mentioned: Blood draws

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
  • "Patients will also have a medical history, blood tests, imaging studies, and other tests."
  • "Patients will be followed for 3 months after the surgical procedure to determine effectiveness of DBS treatment."
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 looks at how deep brain stimulation (DBS) surgery affects movement disorders in adults. DBS uses a device under the skin in the chest to send signals to brain areas that control movement. Researchers will also study brain and nerve cell activity during surgery.

Background: \- Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest. It is used to stimulate the areas of the brain that affect movement. Stimulating these areas helps to block the nerve signals that cause abnormal movements. Researchers also want to record the brain function of people with movement disorders during the surgery. Objectives: * To study how DBS surgery affects Parkinson s disease, dystonia, and tremor. * To obtain information on brain and nerve cell function during DBS surgery. Eligibility: \- People at least 18 years of age who have movement disorders, like Parkinson's disease, essential tremor, and dystonia. Design: * Researchers will screen patients with physical and neurological exams to decide whether they can have the surgery. Patients will also have a medical history, blood tests, imaging studies, and other tests. Before the surgery, participants will practice movement and memory tests. * During surgery, the stimulator will be placed to provide the right amount of stimulation for the brain. Patients will perform the movement and memory tests that they practiced earlier. * After surgery, participants will recover in the hospital. They will have a followup visit within 4 weeks to turn on and adjust the stimulator. The stimulator has to be programmed and adjusted over weeks to months to find the best settings. * Participants will return for followup visits at 1, 2, and 3 months after surgery. Researchers will test their movement, memory, and general quality of life. Each visit will last about 2 hours.

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 understand the study and agree to take part.
  • Have one of these conditions: Parkinson’s disease with no known cause that medicines do not control well; primary dystonia, which causes muscle tightening and twisting, that does not respond to treatment; or essential tremor, which causes shaking, that medicines do not control well or that greatly limits daily activities.
  • Have the diagnosis confirmed by the NIH movement disorder and DBS surgery teams, who must also decide that DBS is right for you.

Who can't join

  • Be unable or unwilling to understand and agree to the research procedures.

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 provide informed consent. Have a clinical diagnosis of one of the following as confirmed by the NIH movement disorders clinic team and the multi-disciplinary DBS surgical conference, and deemed as appropriate for the use of Deep Brain Stimulation therapy: * idiopathic PD not adequately controlled with medication or * primary dystonia that is medically refractory, or * ET that is not adequately controlled by medications or constitutes a significant functional disability. EXCLUSION CRITERIA: Candidates will be excluded if they: Are unable or unwilling to give informed consent to the research procedures.

Study sites (1)

MD