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NCT02119611 · ClinicalTrials.gov registry record · NA
Deep Brain Stimulation Therapy in Movement Disorders
A NA study of Parkinson's Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT02119611 is a NA study of Parkinson's Disease that is actively recruiting participants, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 300 participants, below the 640-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02119611, a NA study of Parkinson's Disease, is actively recruiting participants, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study 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....
Conditions Studied
Interventions
- DEVICE Deep Brain Stimulation management
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2014-04-02 |
| Est. Completion | 2030-12-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02119611
The ClinicalTrials.gov registry entry for NCT02119611 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 640-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (53% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 1 intervention - of which Deep Brain Stimulation management is the first listed.
NCT02119611 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02119611 about?
NCT02119611 is a clinical study titled "Deep Brain Stimulation Therapy in Movement Disorders". 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:...
What is the current status of trial NCT02119611?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2014-04-02. Estimated completion is 2030-12-01.
What conditions does trial NCT02119611 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT02119611?
The interventions under investigation include: Deep Brain Stimulation management (DEVICE).
Who is sponsoring clinical trial NCT02119611?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02119611 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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