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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 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation (Model 7438 Therapy Controller) | Device | Deep brain stimulation (DBS) is a surgical procedure used to treat a variety of disabling neurological symptoms |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| measures of tremor,voltage threshold for optimal tremor control | 10 weeks | |
| Side effects | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Uitti, MD | Mayo Clinic | Principal Investigator |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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