RecruitingNCT04828798Updated Oct 30, 2025

Directional Versus Nondirectional DBS for ET

An interventional study of Deep brain stimulation of the VIM Thalamic nuclei in Essential Tremor, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-10-30.

Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 24
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Read the detailed description

Specific Aims:

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.
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.
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.
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 studied

Essential Tremor

Browse trials for

Essential Tremor 261

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 24 participants (estimated)

Study arms

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
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

Interventions

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

What researchers measure

Primary outcomes

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
Time frame: 3 months

Secondary outcomes

Improvement of tremor
Change in The Essential Tremor Rating Scale (TETRAS) combined score. Range = 0 to112. Higher score = worse outcome.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 3 months

Study locations

1 of 1 sites recruiting

Oregon Health & Science University
Portland, Oregon 97239, United States
- Zoe Fanning · Contact · fanningz@ohsu.edu · 503-494-7772
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT04828798
Lead sponsor: Oregon Health and Science University
Responsible party: Matthew Brodsky (Associate Professor of Neurology, Oregon Health and Science University) — Principal investigator
First posted: Apr 2, 2021
Start date: Apr 1, 2021
Primary completion: Oct 1, 2027 (estimated)
Completion: Oct 1, 2029 (estimated)
Last update: Oct 30, 2025

Study contacts

Zoe Fanning

Contact

fanningz@ohsu.edu

503-494-7772

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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