This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
Intervention Model: Single Group Assignment
Masking: Single (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 ]
    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 ]
  • Side effects [ Time Frame: 10 weeks ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

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 September 21, 2017