Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor

Mayo Clinic

Status

Completed

Conditions

Essential Tremor

Treatments

Device: Deep Brain Stimulation (Model 7438 Therapy Controller)

Study type

Interventional

Funder types

Other

Identifiers

NCT01334814

1324-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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