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NCT Number: NCT04828798

Directional Versus Nondirectional DBS for ET

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.

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deep brain stimulation of the VIM Thalamic nuclei

Device

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

Primary outcomes

  1. Therapeutic window

    Time frame: 3 months

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

Secondary outcomes

  1. Improvement of tremor

    Time frame: 3 months

    Change in The Essential Tremor Rating Scale (TETRAS) combined score. Range = 0 to112. Higher score = worse outcome.

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

    Time frame: 3 months

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

    Time frame: 3 months

    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).

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

    Time frame: 3 months

    Perceptual assessment of voice and speech will be completed with listeners judging a reading sample using a 100mm Visual Analog Scale (VAS).

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Directional Versus Nondirectional Deep Brain Stimulation of the VIM Thalamic Nucleus for Essential Tremor: Assessment of Therapeutic Window, Speech, Gait and Balance

Important dates

Study start
2021
Primary completion
2027
Study completion
2029
First posted
Apr 2, 2021
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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