Deep Brain Stimulation Therapy in Movement Disorders
- Conditions
- Parkinson's Disease
- Interventions
- Device: Deep Brain Stimulation management
- Registration Number
- NCT02119611
- Brief Summary
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.
- Detailed Description
Objective
The purposes of this protocol are:
To provide DBS therapy and follow-up management
To maintain a cohort of patients treated with DBS who can participate in other NIH protocols addressing the efficacy of functional surgery and the relevant physiology.
To collect physiology, programming, and efficacy data related to DBS therapy and motor and cognitive function in these patient populations. All the data collected will be an outcome of standard of care and all analyses will be retrospective.
All treatment under this protocol will be based on the current standard of care for DBS therapy. All tests and study procedures will be administered per standard and routine clinical care; however, the schedule of procedures has been standardized for research purposes. Subjects may be enrolled in the study to support participation in other DBS protocols.
Study Population
Patients 18 years and older with medically refractory PD, dystonia, and/or ET may participate in this study. Other indications will be added with subsequent amendments if FDA approval of deep brain stimulation is extended to other conditions.
Study Design
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 as a therapeutic option per standard of care procedures and routine clinical care. Patients will be evaluated for their eligibility for the procedure and the risk/benefit balance for surgical therapy will be assessed (Lang et al., 2006). After completing the evaluation, a decision will be made on recommending the procedure. At that point the patients will be referred for the surgical intervention to the NIH Surgical Neurology Branch or to collaborating surgeons in the community. If the surgery is performed at the NIH, the Neurology DBS team can be involved in surgical planning, target selection, intraoperative physiology recording and testing, as specified under SNB protocols. After the surgery, the patients will be followed in the NIH DBS clinic and the DBS programming will be initiated and performed as outlined below. The patients will be followed up for at least two years, and then they will have the option to transfer their care back to the neurologists in the community or continue care with the NIH Neurology team until care in the community is available.
In addition, patients can be enrolled in the protocol at various points in relation to DBS surgery.
Data regarding the movement disorder of the subject and observations of their standard of care treatment will be collected. Data may be used for future research questions that are related to subjects movement disorder and/or treatment.
Outcome Measures
1. To evaluate effects of DBS before and after surgery using clinically-generated data on:
1. Severity of PD motor symptoms (measured by the UPDRS III scale)
2. Changes in dystonia severity (measured by the Burke-Fahn-Marsden (BFM) dystonia rating scale (Burke et al., 1985)
3. Changes in tremor severity (measured by the Tremor Rating Scale (TRS))
4. Levels of effective drug therapy for PD patients using the Levodopa Equivalent Drug Dosing (LEDD)
5. Changes in behavior, performance of activities of daily living and complications of therapy as measured by the UPDRS I, II, and IV scales
2. To evaluate effects of DBS before and after surgery on quality of life:
1. For PD patients (measured by UPDRS part II and other scales such as the PDQ-39)
2. For the Dystonia and ET patients (measured by the SF-12 scale)
3. To evaluate radiographic correlation of DBS electrode position and clinical changes
4. To evaluate neurophysiological mechanisms of DBS and relevant basal ganglia physiology
All data collected will be done as standard of care and all analysis will be retrospective.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single-arm Deep Brain Stimulation management Therapy
- Primary Outcome Measures
Name Time Method To maintain a cohort of patients treated with DBS who can participate in other NIH protocols addressing the efficacy of functional surgery and the relevant physiology ongoing To potentially enroll subjects in other NIH studies.
Data collection ongoing All the data collected will be an outcome of standard of care and all analyses will be retrospective
To provide DBS therapy and follow-up management two years a. Severity of PD motor symptoms (measured by the UPDRS III scale) b. Changes in dystonia severity (measured by the Burke-Fahn-Marsden (BFM) dystonia rating scale (Burke et al., 1985) c. Changes in tremor severity (measured by the Tremor Rating Scale (TRS)) d. Levels of effective drug therapy for PD patients using the Levodopa Equivalent Drug Dosing (LEDD) e. Changes in behavior, performance of activities of daily living and complications of therapy as measured by the UPDRS I, II, and IV scales 2. To evaluate effects of DBS before and 1 year after surgery on quality of life: a. For PD patients (measured by UPDRS part II and other scales such as the PDQ-39) b. For the Dystonia and ET patients (measured by the SF-12 scale) 3. To evaluate radiographic correlation of DBS electrode position and clinical changes 4. To evaluate neurophysiological mechanisms of DBS and relevant basal ganglia physiology
- Secondary Outcome Measures
Name Time Method To access other clinical outcome measures related to response to therapy 2 years Data collection
To collect physiology data correlated with motor and cognitive function in these 2 years Data collection
To correlate radiographic data related to DBS electrode position with clinical changes 2 years Data collection
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States