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NCT01581580 · ClinicalTrials.gov registry record · NA

Deep Brain Stimulation Surgery for Movement Disorders

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

Recruiting
Registry status
NA
Development phase
200
Enrollment target
1
Study location

NCT01581580 is a NA study of Parkinson's Disease and Essential Tremor that is actively recruiting participants, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 200 participants, below the 641-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01581580, a NA study of Parkinson's Disease and Essential Tremor, is actively recruiting participants, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

RECRUITING
Registry status
NA
Development phase
200 participants
Enrollment target
1
Study location

Study Summary

Background: \- 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. Objectives: * To study how DBS surgery affects Parkinson s disease, dystonia, and tremor. * To obtain information on brain and nerve cell function during DBS surgery. Eligibility: \- People at least 18 years of age who have movement disorders, like Parkinson's disease, essential tremor, and dystonia. Design: * 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.

Interventions

  • DEVICE Medtronic Activa Tremor Control System
  • PROCEDURE Deep Brain Stimulation

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2011-08-17
Est. Completion 2029-12-01
Phase NA

What the Registry Record Tells You About NCT01581580

The ClinicalTrials.gov registry entry for NCT01581580 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 641-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (69% 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 3 conditions, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions - of which Medtronic Activa Tremor Control System is the first listed.

NCT01581580 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT01581580 about?

NCT01581580 is a clinical study titled "Deep Brain Stimulation Surgery for Movement Disorders". Background: \- 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 ...

What is the current status of trial NCT01581580?

This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2011-08-17. Estimated completion is 2029-12-01.

What conditions does trial NCT01581580 study?

This clinical trial studies the following conditions: Parkinson's Disease, Essential Tremor, Dystonia.

What interventions are being tested in trial NCT01581580?

The interventions under investigation include: Medtronic Activa Tremor Control System (DEVICE), Deep Brain Stimulation (PROCEDURE).

Who is sponsoring clinical trial NCT01581580?

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 NCT01581580 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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