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This will be a single center (OHSU) proof of concept trial to demonstrate that directional deep brain stimulation (DBS) creates a larger therapeutic window for the treatment of essential tremor (ET), effectively treats ET, and minimizes effects on speech, gait and balance compared to nondirectional DBS.
Specific Aims:
To compare the therapeutic window (TW) of directional versus nondirectional deep brain stimulation for treatment of tremor.
Hypothesis: directional DBS will result in a wider TW than nondirectional DBS.
To compare the effects of directional versus nondirectional DBS on speech Hypothesis: Objective and subjective speech impairment will occur to a greater extent in nondirectional DBS versus directional DBS optimized for tremor control.
To compare the effects of directional versus nondirectional DBS on balance and gait Hypothesis: Objective and subjective balance and gait impairment will occur to a greater extent in nondirectional DBS versus directional DBS optimized for tremor control.
To assess efficacy for tremor of nondirectional and directional DBS in an optimized programming configuration Hypothesis: both directional and nondirectional DBS will significantly improve tremor compared to baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Directional deep brain stimulation | Active Comparator | Deep brain stimulation delivered in a directional manner within an axial plane |
|
| Nondirectional deep brain stimulation | Active Comparator | Deep brain stimulation delivered in a nondirectional manner within an axial plane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation of the VIM Thalamic nuclei | Device | Deep brain stimulation of the thalamus, in a directional and nondirectional manner |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic window | Range of therapeutic current from clinical improvement to side effect threshold, measured in milliamps, within a range of 0.0 to 5.0 milliamps | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of tremor | Change in The Essential Tremor Rating Scale (TETRAS) combined score. Range = 0 to112. Higher score = worse outcome. | 3 months |
| Compare the effects of directional versus nondirectional DBS on self perception of speech |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zoe Fanning | Contact | 503-494-7772 | fanningz@ohsu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | 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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Double-blinded crossover design
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Self Perception of speech: Subjects will rate their "ability to speak" on a VAS (from 0 [normal] to 100 mm [worst]) in each condition.
| 3 months |
| Compare the effects of directional versus nondirectional DBS on balance and gait | The Activities-specific Balance Confidence (ABC) scale is a 16-item self-report measure in which participants rate their balance confidence on a 0-100 scale (0 = 0 no confidence, 100 = 100 complete confidence). | 3 months |
| Compare the effects of directional versus nondirectional DBS on perceptual assessment of voice and speech | Perceptual assessment of voice and speech will be completed with listeners judging a reading sample using a 100mm Visual Analog Scale (VAS). | 3 months |