Trial record 19 of 66 for:    "Benign essential tremor syndrome"

Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01334814
First received: March 9, 2010
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Essential Tremor
Device: Deep Brain Stimulation (Model 7438 Therapy Controller)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • sleep quality [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: January 2002
Study Completion Date: January 2010
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Deep Brain Stimulation (Model 7438 Therapy Controller)
    Deep brain stimulation (DBS) is a surgical procedure used to treat a variety of disabling neurological symptoms
    Other Name: Model 7438 Therapy Controller
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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334814

Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Ryan Uitti, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Ryan J. Uitti, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01334814     History of Changes
Other Study ID Numbers: 1324-02
Study First Received: March 9, 2010
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on April 21, 2014