Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor
Primary Purpose
Essential Tremor
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Deep Brain Stimulation (Model 7438 Therapy Controller)
Sponsored by
About this trial
This is an interventional supportive care trial for Essential Tremor
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
sleep quality
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
measures of tremor,voltage threshold for optimal tremor control
Side effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01334814
Brief Title
Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor
Official Title
Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation (Model 7438 Therapy Controller)
Other Intervention Name(s)
Model 7438 Therapy Controller
Intervention Description
Deep brain stimulation (DBS) is a surgical procedure used to treat a variety of disabling neurological symptoms
Primary Outcome Measure Information:
Title
sleep quality
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
measures of tremor,voltage threshold for optimal tremor control
Time Frame
10 weeks
Title
Side effects
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Uitti, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor
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