Directional Versus Nondirectional DBS for ET

NCT04828798 | Recruiting DMC FDA Device

• 1 other identifier: STUDY00020724
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Therapeutic window

  Range of therapeutic current from clinical improvement to side effect threshold, measured in milliamps, within a range of 0.0 to 5.0 milliamps

  3 months

Secondary Outcomes (4)

• Improvement of tremor

  3 months

• Compare the effects of directional versus nondirectional DBS on self perception of speech

  3 months

• Compare the effects of directional versus nondirectional DBS on balance and gait

  3 months

• Compare the effects of directional versus nondirectional DBS on perceptual assessment of voice and speech

  3 months

Study Arms (2)

Directional deep brain stimulation

ACTIVE COMPARATOR

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

Device: Deep brain stimulation of the VIM Thalamic nuclei

Nondirectional deep brain stimulation

ACTIVE COMPARATOR

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

Device: Deep brain stimulation of the VIM Thalamic nuclei

Interventions

Deep brain stimulation of the VIM Thalamic nuclei DEVICE

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

Directional deep brain stimulation; Nondirectional deep brain stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A tremor syndrome of bilateral upper limb action tremor with at least 3 years' duration

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Zoe Fanning

CONTACT

503-494-7772; fanningz@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Model Details: Double-blinded crossover design

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: April 2, 2021
• Study Start: April 1, 2021
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2029
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)