Deep Brain Stimulation for Movement Disorders

The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

This study (11-N-0211) uses deep brain stimulation (DBS) to treat Parkinson’s disease, dystonia, and essential tremor.  DBS is an approved surgical procedure for these neurological conditions which do not respond well to other treatments. The objective of this research is to study normal human biology and disease pathogenesis (natural history) and to collect physiology and efficacy data related to DBS therapy and motor and cognitive function in the study population.

In this study, researchers will provide DBS surgery for up to 100 people (18 years of age or older) with movement disorders that are FDA-approved indications for DBS, including Parkinson’s disease, dystonia, and essential tremor.

DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest.  The stimulator is attached to wires placed into the areas of the brain that affect movement.  Stimulating these areas of the brain helps to block the nerve signals that cause abnormal movements.  The neurostimulator and wires are placed during surgery.  During the surgery, the study investigators will do research procedures that include recording information from wires placed in the brain for surgery, stimulating small areas of the brain through the wires, and having participants do tests of movement, thinking, and reasoning.

Participants in the study will have tests before and after surgery, including brain imaging with MRI and CT scans, tests of thinking and memory, and evaluation of their movement disorder and response to DBS.  These tests are part of standard care for people having DBS surgery.

Participants will have 1-2 outpatient visits before surgery to check eligibility.  Those eligible for the study will be admitted to the hospital for surgery for about a week.  Participants will have an outpatient visit about one week after discharge, then monthly for 3 months, and then once every 3 months for the first year after surgery.  Participants will be seen every 6 months during the second year.  Each visit will last about two hours.  The duration of the study for participants is 2 years.  All study visits take place at the NIH Clinical Center in Bethesda, MD.  At the end of the study, management of the DBS system and participant care will be returned to their own physicians.

Eligibility Criteria:

To be eligible for the study, volunteers must:

• Have Parkinson’s disease, certain types of dystonia, or essential tremor.  In the case of Parkinson’s disease, the condition must improve with levodopa (Sinemet).
• Have tried medications for their movement disorder but still have severe symptoms.
• Be able to provide their own informed consent for this study.

Volunteers will be excluded if they:

• Are pregnant.
• Have dementia, depression, or another psychiatric disorder.
• Have metal in their body which would make having an MRI scan unsafe—such as pacemakers, medication pumps, aneurysm clips, metallic prostheses, shrapnel fragments, permanent eye liner or small metal fragments in the eye.
• Cannot lie comfortably on their back for up to one hour in the MRI scanner.
• Have any medical condition that would make their participation unsafe.
• Have movement disorder symptoms due to a known cause.

Study Design: 

Study Locations: 

For more information:

Contact:  Gretchen Scott, RN; Tel: 301-496-2921; or the Patient Recruitment Office; Tel: 800-411-1222;

Email:  SNBrecruiting@nih.gov

Last Reviewed November 20, 2012