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Набор по приглашению NCT06642454

A Randomized Double-Blind Active-Controlled Crossover Trial of Respiratory-Gated Versus Non-Gated Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Motor and Non-Motor Symptoms in Parkinson's Disease

Без фазы С лечением Parkinson Disease Apathy Sleep Disorder Motor Disorders

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: Transcutaneous auricular vagus nerve stimulation.
Кому может быть актуально
Состояния в реестре: Parkinson Disease, Apathy, Sleep Disorder, Motor Disorders. Базовые параметры: 40 лет — 80 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this clinical trial is to compare the effects of different modes and frequencies of transcutaneous auricular vagus nerve stimulation (taVNS) on motor and non-motor symptoms in people with Parkinson's disease. The main questions it aims to answer are: Which mode and frequency of taVNS is most effective in improving motor or non-motor symptoms? Are there any side effects or safety concerns with different taVNS frequencies? Researchers will compare three types of taVNS: 25 Hz non-expiratory gated, 25 Hz expiratory gated, and 100 Hz expiratory gated stimulation. Participants will: Receive each type of taVNS in three 2-week cycles, with 2-month breaks between cycles Undergo neuropsychological assessments, imaging, eye-tracking, and biological sample collection before and after each cycle.

Подробное описание

This study employs a three-cycle crossover design to compare the effects of three different modes and frequencies of transcutaneous auricular vagus nerve stimulation (taVNS). The interventions include: 25 Hz non-expiratory gated taVNS, 25 Hz expiratory gated taVNS, and 100 Hz expiratory gated taVNS. Participants will be randomly assigned to one of three groups, with each group receiving a different intervention during each cycle, lasting 2 weeks per cycle. A 2-month washout period will be implemented between cycles to eliminate any carryover effects.The study design will include neuropsychological assessments, imaging, eye-tracking data collection, and biological specimen collection before and after each intervention.

Вмешательства

  • Другое Transcutaneous auricular vagus nerve stimulation
    Stimulation Target: Left cymba conchae. 25 Hz Non-Expiratory Gated taVNS: Stimulation is delivered for 30 seconds at a frequency of 25 Hz, followed by a 30-second interval. 25 Hz Expiratory Gated taVNS: One second of stimulation occurs during exhalation at a frequency of 25 Hz. 100 Hz Expiratory Gated taVNS: One second of stimulation is administered during exhalation at a frequency of 100 Hz.

Первичные конечные точки

  • Unified Parkinson's Disease Rating Scale Part III (UPDRS-III) [Срок оценки: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
  • Non-Motor Symptoms Scale, Second Version (NMSS-2) [Срок оценки: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
Вторичные конечные точки (8)
  • Apathy Motivation Index (AMI) [Срок оценки: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
  • Apathy Evaluation Scale (AES) [Срок оценки: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
  • Fatigue Scale-14 (FS-14) [Срок оценки: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
  • REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) [Срок оценки: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
  • Hamilton Anxiety Rating Scale (HAMA) [Срок оценки: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
  • Hamilton Depression Rating Scale (HAMD-17) [Срок оценки: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]
  • Epworth Sleepiness Scale (ESS) [Срок оценки: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks]

Критерии участия

Критерии включения

  • Age: 40 years or older.
  • Confirmed diagnosis of Parkinson's disease (PD) per the United Kingdom Brain Bank Criteria by a neurologist specialized in movement disorders.
  • Participants must be on a stable dose of all medications for at least 2 weeks, with no planned adjustments to anti-PD medications for the next 3 months.
  • In the second version of the Non-Motor Symptoms Scale (NMSS-2) for Parkinson's disease, a score of ≥1 is assigned to either question 4 or question 8.
  • Participants must be in good mental health and capable of completing behavioral tests and transcutaneous auricular vagus nerve stimulation.

Критерии исключения

  • Mini-Mental State Examination (MMSE) score <24.
  • History of head injury, stroke, or other neurological disorders.
  • Includes implanted cardiac pacemakers post-DBS operation, local infections, ear loss, or metal implants at the stimulation site.
  • Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.
  • Inability to complete follow-up assessments.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 2 центра
  • Cognitive Neuropsychology Lab Anhui Medical University — Хэфэй
  • Cognitive Neuropsychology Lab Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT06642454 · PD-TaVNS-OPEN

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗