Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor - Full Text View

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:

Genetics Home Reference related topics: essential tremor

MedlinePlus related topics: Tremor

U.S. FDA Resources

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:

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 May 19, 2013