Directional Versus Nondirectional DBS for ET

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Therapeutic window [Срок оценки: 3 months]

Вторичные конечные точки (4)

• Improvement of tremor [Срок оценки: 3 months]
• Compare the effects of directional versus nondirectional DBS on self perception of speech [Срок оценки: 3 months]
• Compare the effects of directional versus nondirectional DBS on balance and gait [Срок оценки: 3 months]
• Compare the effects of directional versus nondirectional DBS on perceptual assessment of voice and speech [Срок оценки: 3 months]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Oregon Health & Science University — Portland

Идентификаторы

NCT: NCT04828798 · STUDY00020724

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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