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Use of Two Deep Brain Stimulation (DBS) Electrodes to Treat Post-Traumatic Tremor

NCT00954421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-07-25

Study results available
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Summary

The purpose of this research study is to:

1. Determine whether deep brain stimulation (DBS) with two leads (very thin coiled wires) placed unilaterally (on one side of the brain) is beneficial to patients with multiple sclerosis (MS) tremor.
2. Compare the two different locations of the DBS lead placement in effectiveness for treatment of muscle tremors that do not respond to treatment with medication caused by multiple sclerosis.
3. Evaluate any side effects that may result from the two DBS leads.

Conditions

Interventions

DEVICE

Deep Brain Stimulation

Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Medtronic

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Kelly Foote, MD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2012-06-30
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00954421 on ClinicalTrials.gov