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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
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Essential Tremor

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 9, 2010
    Last Updated
    January 4, 2012
    Sponsor
    Mayo Clinic
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    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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