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

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.

Study Overview

• Status: Recruiting
• Conditions: Essential Tremor
• Intervention / Treatment: Device: Deep brain stimulation of the VIM Thalamic nuclei

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zoe Fanning; Phone Number: 503-494-7772; Email: fanningz@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Contact: Zoe Fanning; Phone Number: 503-494-7772; Email: fanningz@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Directional deep brain stimulation; Deep brain stimulation delivered in a directional manner within an axial plane	Device: Deep brain stimulation of the VIM Thalamic nuclei; Deep brain stimulation of the thalamus, in a directional and nondirectional manner
Active Comparator: Nondirectional deep brain stimulation; Deep brain stimulation delivered in a nondirectional manner within an axial plane	Device: Deep brain stimulation of the VIM Thalamic nuclei; Deep brain stimulation of the thalamus, in a directional and nondirectional manner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of tremor	Change in The Essential Tremor Rating Scale (TETRAS) combined score. Range = 0 to112. Higher score = worse outcome.	3 months
Compare the effects of directional versus nondirectional DBS on self perception of speech	Self Perception of speech: Subjects will rate their "ability to speak" on a VAS (from 0 [normal] to 100 mm [worst]) in each condition.	3 months
Compare the effects of directional versus nondirectional DBS on balance and gait	The Activities-specific Balance Confidence (ABC) scale is a 16-item self-report measure in which participants rate their balance confidence on a 0-100 scale (0 = 0 no confidence, 100 = 100 complete confidence).	3 months
Compare the effects of directional versus nondirectional DBS on perceptual assessment of voice and speech	Perceptual assessment of voice and speech will be completed with listeners judging a reading sample using a 100mm Visual Analog Scale (VAS).	3 months

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Essential Tremor
• Other Study ID Numbers: STUDY00020724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes