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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: Recruiting NA study of Parkinson's Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

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 633-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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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....

Primary Outcome

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

Conditions Studied

Interventions

  • DEVICE Deep Brain Stimulation management

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2014-04-02
Est. Completion 2030-12-01
Phase NA

What NCT02119611 shows while recruiting

NCT02119611 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 633-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (53% lower).

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 a single indexed study location in 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.

Similar trials for Parkinson's Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02119611's enrollment target sits among peer trials

300 27th of 158 higher than 132 of 158 other Parkinson's Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Parkinson's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02119611, the US trial registry maintained by the National Library of Medicine. NCT02119611 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.