Directional Versus Nondirectional DBS for ET

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT04828798
Status
Recruiting
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Conditions

  • Essential Tremor

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Deep brain stimulation of the VIM Thalamic nuclei — DEVICE
    Deep brain stimulation of the thalamus, in a directional and nondirectional manner

Study Details

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.

Key Dates

Start date
Apr 1, 2021
Status verified
Oct 2025
Primary completion
Oct 1, 2027
Completion
Oct 1, 2029

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Directional deep brain stimulation
    Deep brain stimulation delivered in a directional manner within an axial plane
  • Active Comparator: Nondirectional deep brain stimulation
    Deep brain stimulation delivered in a nondirectional manner within an axial plane

Primary Outcome Measure

Therapeutic window [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science UniversityPortlandOregon97239
Zoe Fanning
[email protected]
503-494-7772

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By research site
Oregon Health & Science University· Portland, OR

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