Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor

NCT ID: NCT01334814

Last Updated: 2012-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2010-01-31

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.

Conditions

Essential Tremor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Interventions

Deep Brain Stimulation (Model 7438 Therapy Controller)

Deep brain stimulation (DBS) is a surgical procedure used to treat a variety of disabling neurological symptoms

Intervention Type: DEVICE

Other Intervention Names

Model 7438 Therapy Controller

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Ryan Uitti, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Other Identifiers

1324-02

Identifier Type: -

Identifier Source: org_study_id