Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor

Not Applicable

Completed

• Conditions: Essential Tremor

• Registration Number: NCT01334814
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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 Timeline

• Study Start: 2002-01
• Primary Completion: 2005-09
• Study Completion: 2010-01
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2011-04-12
• Study First Posted: 2011-04-13
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-04
• Last Update Posted: 2012-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
sleep quality	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.

Secondary Outcome Measures

Name	Time	Method
measures of tremor,voltage threshold for optimal tremor control	10 weeks
Side effects	10 weeks