NCT01334814

Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2002-01-01
• Primary completion: 2005-09-01
• Completion: 2010-01-01
• First posted: 2011-04-13
• Last updated: 2012-01-06