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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Essential Tremor
Tremor
Central Nervous System Diseases
Dyskinesias
Movement Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014