Essential Tremor
Conditions
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.
Interventions
DEVICEDeep Brain Stimulation (Model 7438 Therapy Controller)
Deep brain stimulation (DBS) is a surgical procedure used to treat a variety of disabling neurological symptoms
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sleep quality | 10 weeks | 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
| Measure | Time frame |
|---|---|
| measures of tremor,voltage threshold for optimal tremor control | 10 weeks |
| Side effects | 10 weeks |
Outcome results
None listed