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Recruiting NCT04828798

Directional Versus Nondirectional DBS for ET

No phase Interventional Essential Tremor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep brain stimulation of the VIM Thalamic nuclei.
Who it may be relevant to
Registry conditions: Essential Tremor. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Therapeutic window [Time frame: 3 months]
Secondary outcome measures (4)
  • Improvement of tremor [Time frame: 3 months]
  • Compare the effects of directional versus nondirectional DBS on self perception of speech [Time frame: 3 months]
  • Compare the effects of directional versus nondirectional DBS on balance and gait [Time frame: 3 months]
  • Compare the effects of directional versus nondirectional DBS on perceptual assessment of voice and speech [Time frame: 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Oregon Health & Science University — Portland

Identifiers

NCT: NCT04828798 · STUDY00020724

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗