NCT04828798

Directional Versus Nondirectional DBS for ET

Directional Versus Nondirectional Deep Brain Stimulation of the VIM Thalamic Nucleus for Essential Tremor: Assessment of Therapeutic Window, Speech, Gait and Balance

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DEVICE	Deep brain stimulation of the VIM Thalamic nuclei	Deep brain stimulation of the thalamus, in a directional and nondirectional manner

Timeline

• Start date: 2021-04-01
• Primary completion: 2027-10-01
• Completion: 2029-10-01
• First posted: 2021-04-02
• Last updated: 2025-10-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study