Essential Tremor
Conditions
Brief summary
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.
Detailed description
Specific Aims: 1. 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. 2. 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. 3. 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. 4. 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.
Interventions
DEVICEDeep brain stimulation of the VIM Thalamic nuclei
Deep brain stimulation of the thalamus, in a directional and nondirectional manner
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Double-blinded crossover design
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* A tremor syndrome of bilateral upper limb action tremor with at least 3 years' duration
Exclusion criteria
* Patients who have decided not to receive DBS for control of their medication-refractory essential tremor. * Patients with secondary tremor (ie not Essential Tremor), such as side effects from medications, secondary to another identified neurologic disease (eg multiple sclerosis, -----Parkinson's disease, dystonia). * Prior history of deep brain stimulation. * Prior history of thalamotomy. * A history or signs of dystonia, ataxia or parkinsonism. * Task specific tremor. * Orthostatic tremor. * Patients with cardiac pacemakers, defibrillators, or neurostimulators. * Patients who require MRI, ECT, rTMS, or diathermy. * Subjects with other type of neurological disease or injury.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic window | 3 months | Range of therapeutic current from clinical improvement to side effect threshold, measured in milliamps, within a range of 0.0 to 5.0 milliamps |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of tremor | 3 months | Change in The Essential Tremor Rating Scale (TETRAS) combined score. Range = 0 to112. Higher score = worse outcome. |
| Compare the effects of directional versus nondirectional DBS on self perception of speech | 3 months | Self Perception of speech: Subjects will rate their ability to speak on a VAS (from 0 \[normal\] to 100 mm \[worst\]) in each condition. |
| Compare the effects of directional versus nondirectional DBS on balance and gait | 3 months | 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). |
| Compare the effects of directional versus nondirectional DBS on perceptual assessment of voice and speech | 3 months | Perceptual assessment of voice and speech will be completed with listeners judging a reading sample using a 100mm Visual Analog Scale (VAS). |
Countries
United States
Contacts
Primary ContactZoe Fanning
Outcome results
None listed