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This study evaluates the effectiveness of tremor control using various strategies for implementing demand-driven thalamic deep brain stimulation (DBS) for essential tremor. Therapeutic stimulation at the Vim nucleus of the thalamus will be initiated and modulated using signals derived from external sensors (e.g. EMG, accelerometer) and cortical or thalamic electrodes.
Essential tremor is effectively treated with deep brain stimulation of the ventralis intermedius nucleus of the thalamus, presumably because high-frequency stimulation disrupts aberrant cerebellar-thalamic input. For the most part, patients with essential tremor have a kinetic tremor that is present or worsened with movement. However, DBS therapy is currently continuous, and thus, stimulation occurs when the patient will not benefit symptomatically from treatment. This exposes the patient to unnecessary stimulation, which can lead to unnecessary usage of battery, unnecessary exposure to stimulation side-effects, and can possibly contribute to tolerance to DBS therapy.
One possible solution is selective stimulation when movement is required. This study will determine signals predictive of motor activity using external sensors such as EMG, and cortical biomarkers of real and imaginary movement that are well-characterized.
The primary aim is to demonstrate successful initiation and modulation of DBS therapy using the Activa PC+S system and implanted cortical or thalamic electrodes. Putative improvements in battery usage related to stimulation on-time and definition of coupling signals between thalamus and cortex that characterize tremor state are secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activa PC+S | Experimental | Patients will be implanted with standard DBS electrodes for treatment of essential tremor, at the Vim nucleus of the thalamus, and an additional subdural electrode array overlying hand motor cortex.. The patient will receive standard of care programming for thalamic stimulation for essential tremor. During research study visits, implementation and evaluation of closed-loop DBS using the PC+S system will be performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activa PC+S | Device | Implementation of closed loop DBS for essential tremor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Adverse events will be tracked using CTCAE terminology. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Battery usage using demand-driven strategies for tremor control | Battery usage will be measured as stimulation on-time and voltage over time using demand-driven stimulation paradigms versus continuous stimulation paradigm. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Ko, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Department of Neurological Surgery | Seattle | Washington | 98195 | United States |
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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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