Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor

January 4, 2012 updated by: Mayo Clinic
The proposed study is a randomized, single blind trial of intermittent versus continuous stimulation among essential tremor (ET) patients with a chronic history of continuous stimulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed study is a randomized, single blind trial of intermittent versus continuous stimulation among essential tremor (ET) patients with a chronic history of continuous stimulation. The trial is 10 weeks in length with clinical evaluations (about 60 minutes) performed on weeks 1, 2, 6, and 10, and phone interviews (about 5 minutes) on weeks 3, 4, 5, 7, 8, and 9. The study includes outcome measures of tremor, stimulation-induced side effects, sleep quality, and voltage threshold for optimal tremor control and sustained side-effects.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • individuals with essential tremor who are at least 6 months status-post thalamic stimulator placement
  • maintained a consistent chronic or intermittent stimulation schedule for at least 4 consecutive weeks prior to study enrollment
  • no changes in stimulation parameters for at least 2 consecutive months prior to study enrollment

Exclusion Criteria:

  • patients with clinically significant dementia (i.e., a score less than 24 out of 30 on the Mini Mental Status Exam14)
  • women who are not post-menopausal
  • patients with other significant neurological or psychiatric disease other than essential tremor
  • patients treated with pallidotomy or thalamotomy
  • patients with significant psychiatric disturbance as determined by Diagnostic and Statistical Manual-IV criteria which would make informed consent/cooperation problematic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep quality
Time Frame: 10 weeks
The trial is 10 weeks in length with clinical evaluations (about 60 minutes) performed on weeks 1, 2, 6, and 10, and phone interviews (about 5 minutes) on weeks 3, 4, 5, 7, 8, and 9.
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
measures of tremor,voltage threshold for optimal tremor control
Time Frame: 10 weeks
10 weeks
Side effects
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Ryan Uitti, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

March 9, 2010

First Submitted That Met QC Criteria

April 12, 2011

First Posted (Estimate)

April 13, 2011

Study Record Updates

Last Update Posted (Estimate)

January 6, 2012

Last Update Submitted That Met QC Criteria

January 4, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1324-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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