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Идёт набор NCT05506085

Deep Brain Stimulation for Laryngeal Dystonia: From Mechanism to Optimal Application

— Наблюдательное Laryngeal Dystonia Adductor Spastic Dysphonia of Dystonia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Deep Brain Stimulation.
Кому может быть актуально
Состояния в реестре: Laryngeal Dystonia, Adductor Spastic Dysphonia of Dystonia. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

Deep Brain Stimulation (DBS) is a neurosurgical procedure used to treat tremors, and dystonia. This study will enroll people who have a form of focal dystonia that affects their vocal cords called Adductor Laryngeal dystonia (ADLD). Participants will undergo Deep Brain Stimulation surgery to treat laryngeal dystonia as part of their clinical care. Before surgery, as part of the study they will have specialized testing to study the movement of the vocal cords, as well as functional magnetic resonance imaging (fMRI). While in the operating room, researchers will examine brain waves to better understand how faulty brain firing patterns lead to dystonia. After surgery, and activation of the deep brain stimulator, participants will repeat speech testing and vocal cord imaging as well as magnetic resonance imaging (MRI).

Вмешательства

  • Устройство Deep Brain Stimulation
    Deep Brain Stimulation of Globus Pallidus interna

Первичные конечные точки

  • Change in total number of Vocal fold movements [Срок оценки: Before surgery, within 24 hours after surgery, 6 -9 months after surgery]
  • Change in Acoustic voice recordings [Срок оценки: Before surgery, within 24 hours after surgery, 6-9 months after surgery]
  • Microelectrode recording [Срок оценки: during surgery]
Вторичные конечные точки (6)
  • Change in Neuropsychological testing: Trails A [Срок оценки: Before surgery, and 6-9 months after surgery]
  • Change in Neuropsychological testin: Trails B [Срок оценки: Before surgery, and 6-9 months after surgery]
  • Change in Neuropsychological testing: Controlled Oral Word Association Animal fluency [Срок оценки: Before surgery, and 6-9 months after surgery]
  • Change in Resting state Functional Magnetic Resonance Imaging (fMRI) [Срок оценки: before surgery and 6-9 months after surgery]
  • Change in Voice Handicap Index [Срок оценки: before surgery and 6-9 months after surgery]
  • Change in Speech Intelligibility [Срок оценки: before surgery and 6-9 months after surgery]

Критерии участия

Критерии включения

  • Patients with ADLD and ADLD plus tremor, as diagnosed by routine clinical examination by laryngologist, speech language pathologist, and neurologist.
  • Patients undergoing globus pallidus interna (GPi) deep brain stimulation (DBS) for ADLD with tremor
  • Age range of 18-80 years
  • Native speakers of American English will be recruited since there are known differences in voice and neural signals of native and non-native speakers
  • No evidence for dementia as assessed by neurologist.
  • No evidence for severe untreated mood disorder as assessed by neurologist, or as evident on self-report (Beck Depression Inventory-II score > 29, Beck Anxiety Inventory Score > 26.
  • At least 3 months since last botulinum toxin injection and the patients would need to be fully symptomatic with no residual effects of botulinum toxin on voice quality.

Критерии исключения

  • Individuals younger than 18 years and older than 80 years of age.
  • Women who plan to become pregnant during the study period or are currently breastfeeding.
  • Prior history of stroke, brain surgery, or other neurological disorder besides the one under study.
  • Prior laryngeal framework surgeries or other disorders affecting the vocal folds
  • Patients who are asymptomatic due to treatment with botulinum toxin into the vocal folds.
  • Presence of ferromagnetic implants and cardiac implants that would be contraindicated to MRI
  • Gagging or discomfort that would preclude the placement of the endoscope to visualize the larynx
  • Dementia, severe depression or severe anxiety.
  • Any clinical condition or medication judged by the investigators to potentially preclude the patient from safely completing awake brain surgery and research protocols.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Indiana University — Indianapolis

Идентификаторы

NCT: NCT05506085 · 14578

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗