Deep Brain Stimulation Surgery for Movement Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01581580|
Recruitment Status : Recruiting
First Posted : April 20, 2012
Last Update Posted : August 9, 2018
- 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.
- To study how DBS surgery affects Parkinson s disease, dystonia, and tremor.
- To obtain information on brain and nerve cell function during DBS surgery.
- People at least 18 years of age who have movement disorders, like Parkinson's disease, essential tremor, and dystonia.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Essential Tremor Dystonia||Procedure: Deep Brain Stimulation||Not Applicable|
The objective of this protocol is to provide DBS surgery and to collect physiology and efficacy data related to DBS therapy and motor and cognitive function in people with medically refractory Parkinson s disease (PD), dystonia, and essential tremor (ET). All treatment under this protocol will be based on the current standard of care for DBS surgery.
Patients 18 years and older with medically refractory PD, dystonia and/or ET may participate in this study.
The treatment that is rendered in this protocol is standard of care for PD, dystonia, and ET. Patients confirmed to have medically refractory PD, dystonia or ET will be offered DBS. The therapeutic goal of this procedure is to implant chronically stimulating macroelectrodes in the basal ganglia or thalamic nuclei in order to alleviate the symptoms of PD, dystonia or ET. Pre- and post-operative imaging will be used to precisely localize electrode locations within the brain and will be correlated with measures of clinical efficacy and recorded intra-operative neural activity. Intra-operative microelectrode recordings, as well as micro- and macroelectrode electrical stimulation, will be used to confirm positioning of electrode leads. Intra-operative electrode recordings will also be used to investigate the neurophysiological mechanisms of deep brain stimulation and to explore the neural circuits underlying motor and cognitive processing in the basal ganglia. Intraoperative physiology will be used for clinical and research purposes. Patients will be followed for 3 months after the surgical procedure to determine effectiveness of DBS treatment.
The primary goal of this protocol is to determine the physiology and efficacy of DBS surgery for movement disorders. Efficacy outcome measures include the change in motor symptoms, as measured by the UPDRS III scale, the Burke-Fahn-Marsden (BFM) dystonia rating scale, and the Tremor Rating Scale before and 3 months after treatment. Secondary measures include 1) levels of effective drug therapy before and after surgery; 2) change in behavior and performance of activities of daily living; 3) complications of therapy as measured by the UPDRS I, II, and IV scales before and after surgery and the SF-12 score; 4) radiographic correlation of DBS electrode position and clinical changes; and 5) neurophysiological mechanisms of DBS and motor and cognitive function in the basal ganglia.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Deep Brain Stimulation Surgery for Movement Disorders|
|Study Start Date :||July 12, 2011|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||March 1, 2021|
- Change in UPDRS III scale, Burke-Fahn-Marsden (BFM) scale, and Tremor Rating Scale before and after treatment. [ Time Frame: 3 months ]
- Levels of effective drug therapy before/after surgery.
- Radiographic correlation of DBS electrode position and clinical changes.
- Neurophysiological mechanisms of DBS and motor/cognitive function in basal ganglia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581580
|Contact: Gretchen C Scott, R.N.||Not Listed||SNBrecruiting@nih.gov|
|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 Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Kareem A Zaghloul, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|