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

Multiple Sclerosis Clinical Trial

Official title: Use of Two DBS Electrodes to Treat Post-Traumatic Tremor

Status Completed

Clinical Trial 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.

Clinical Trial Description

Surgical treatment of disabling multiple sclerosis (MS) tremor that does not respond to medication has proven difficult. To date, there have been no prospective blinded studies to evaluate efficacy of surgical treatments for these tremors. Based on prior data, this study will examine the use of 2 DBS electrodes on the same side of the brain in the thalamus region (one at an area referred to as the "ventralis intermedius nucleus/ventralis oralis posterior nucleus border," or "VIM," and one at a region called the "ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border," or "VO") for treatment of MS tremor. This study will test the effectiveness of VIM combined with, and independent of, VO DBS, and characterize safety, benefits and side effects of this procedure for treatment of MS-related tremors. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis

• NCT number: NCT00954421
• Study type: Interventional
• Source: University of Florida
• Status: Completed
• Phase: N/A
• Start date: November 2006
• Completion date: December 2013