Recruiting

DBS vs. Nondirectional DBS

Sponsor:

Oregon Health and Science University

Code:

NCT04828798

Conditions

Essential Tremor

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Deep brain stimulation of the VIM Thalamic nuclei

Study Details

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.

Conditions

Essential Tremor

Study ID

NCT04828798

Start date

Apr 1, 2021

Status verified date

Oct, 2025

Completion date

Oct 1, 2029

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Deep brain stimulation of the VIM Thalamic nuclei

Deep brain stimulation of the thalamus, in a directional and nondirectional manner

Primary outcome measure

  • Therapeutic window [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Zoe Fanning

503-494-7772fanningz@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Zoe Fanning

503-494-7772fanningz@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-10-30.