Clinical trial NCT04828798: Directional Versus Nondirectional DBS for ET
Official title: Directional Versus Nondirectional Deep Brain Stimulation of the VIM Thalamic Nucleus for Essential Tremor: Assessment of Therapeutic Window, Speech, Gait and Balance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Essential Tremor
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blinded crossover design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Therapeutic window
timeFrame: 3 months
Secondary outcomes:
measure: Improvement of tremor
timeFrame: 3 months
measure: Compare the effects of directional versus nondirectional DBS on self perception of speech
timeFrame: 3 months
measure: Compare the effects of directional versus nondirectional DBS on balance and gait
timeFrame: 3 months
measure: Compare the effects of directional versus nondirectional DBS on perceptual assessment of voice and speech
timeFrame: 3 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References: