Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor

Essential Tremor Clinical Trial

Official title:

Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334814
• Other study ID #: 1324-02
• Status: Completed
• Phase: N/A
• First received: March 9, 2010
• Last updated: January 4, 2012
• Start date: January 2002
• Est. completion date: January 2010

Study information

• Verified date: January 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2010
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep quality	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.	10 weeks	No
Secondary	measures of tremor,voltage threshold for optimal tremor control		10 weeks	No
Secondary	Side effects		10 weeks	No