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Идёт набор NCT06002581

Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease

Без фазы С лечением Parkinson's Disease

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: rTMS real stimulation stage1, rTMS shame stimulation stage1, rTMS real stimulation stage 2.
Кому может быть актуально
Состояния в реестре: Parkinson's Disease. Базовые параметры: 50 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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Официальное название

Clinical Study on the Efficacy and Safety of rTMS Regulating Slow-wave Sleep to Delay the Progression of Parkinson's Disease

Обзор

At present, no drug therapy has been proven to delay the progression of Parkinson's disease (PD). rTMS, as a non-invasive neuromodulation method, can regulate Slow-wave sleep (SWS). SWS is recognized closely related to neurodegeneration. However, there has been no clinical studies on if rTMS could delay the progression of PD by regulating SWS. The main purpose of this study is to explore the changes of SWS in non-rapid eye movement (NREM) sleep period in PD patients by using rTMS, and the relationship with potential improvements of SWS and motor symptom delay. The study aims to find a potential new treatment strategy to delay the neurodegenerative process in PD patients by modulating SWS by rTMS.

Вмешательства

  • Устройство rTMS real stimulation stage1
    In the first stage, the early treatment group use low-frequency rTMS real stimulation,
  • Устройство rTMS shame stimulation stage1
    In the first stage, the control group (delayed treatment group) all use sham stimulation.
  • Устройство rTMS real stimulation stage 2
    In the second stage, both the early treatment group and the control group (delayed treatment group) will be treated with true stimulation low-frequency rTMS.

Первичные конечные точки

  • Change of Motor Function in PD by Low Frequency rTMS Stimulation [Срок оценки: Day14]
Вторичные конечные точки (9)
  • Effects of low-frequency rTMS stimulation on motor symptoms [Срок оценки: Day28,Day56]
  • Measurement of improved balance function in patients with Parkinson's disease [Срок оценки: Day14,Day28,Day56]
  • Assessment of sleep structure in patients with Parkinson's disease [Срок оценки: Day14,Day28,Day56]
  • Effects of low-frequency rTMS stimulation on anxiety [Срок оценки: Day14,Day28,Day56]
  • Effects of low-frequency rTMS stimulation on cognition [Срок оценки: Day14,Day28,Day56]
  • Effects of low-frequency rTMS stimulation on cortical excitability [Срок оценки: Day14,Day28]
  • Effects of low-frequency rTMS stimulation on depression [Срок оценки: Day14,Day28,Day56]
  • Assessment of daytime sleepiness in patients with Parkinson's disease [Срок оценки: Day14,Day28,Day56]
  • Effects of low-frequency rTMS stimulation on gait [Срок оценки: Day14,Day28,Day56]

Критерии участия

Критерии включения

  • Meet the clinically definite or clinically probable PD according to the MDS 2015 version.
  • Chinese Han population (three generations), age greater than or equal to 50 years old, less than or equal to 80 years old, male or female.
  • Hoehn-Yahr stages 1-4.
  • The dose of levodopa drug therapy was stable three weeks before enrollment and during the follow-up period.
  • Right-handed.
  • The patient signed a written informed consent.

Критерии исключения

  • Any form of Parkinsonism other than primary PD.
  • Those who have received neurosurgical intervention or stereotaxic brain surgery for PD, or have previously received TMS treatment.
  • Cognitive dysfunction (MMSE ≤ 24 points) or those who cannot cooperate with the scale score.
  • Persons with mental disabilities.
  • Pregnant women.
  • There are contraindications for rTMS treatment.
  • There are contraindications for MRI examination.
  • Baseline PSG suggests other sleep disorders such as moderate to severe OSAS; BMI>=30.
  • Patients who are addicted to alcohol, taking SSRIs, TCAs, sedative hypnotics, histamine antagonists and other drugs and food that may affect NREM and REM sleep structure.
  • Those who are unwilling to participate in the study or unable to sign the informed consent form; and other circumstances that the researcher considers inappropriate to participate in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT06002581 · CCTR-2022B05

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗