Directional Versus Nondirectional DBS for ET

Oregon Health & Science University (OHSU)

Status: Enrolling

Conditions: Essential Tremor

Treatments: Device: Deep brain stimulation of the VIM Thalamic nuclei

Study type: Interventional

Funder types: Other

Identifiers

NCT04828798

STUDY00020724

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

24 participants in 2 patient groups

Directional deep brain stimulation

Active Comparator group

Description:

Deep brain stimulation delivered in a directional manner within an axial plane

Treatment:

Device: Deep brain stimulation of the VIM Thalamic nuclei

Nondirectional deep brain stimulation

Active Comparator group

Description:

Deep brain stimulation delivered in a nondirectional manner within an axial plane

Treatment:

Device: Deep brain stimulation of the VIM Thalamic nuclei