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Идёт набор NCT06383247

The Efficacy and Safety of Precision REpetitive Transcranial Magnetic Stimulation in Alleviating Motor Symptom in Parkinson's Disease

Без фазы С лечением Parkinson Disease Transcranial Magenetic Stimualtion Supplementary Motor Area

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: transcranial magnetic stimulation.
Кому может быть актуально
Состояния в реестре: Parkinson Disease, Transcranial Magenetic Stimualtion, Supplementary Motor Area. Базовые параметры: от 40 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

A Randomized, Double-blind, Multicenter, Placebo-controlled Trial (PRESS-PD)

Обзор

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive and widely used neuromodulation technology. Small sample studies have shown that rTMS treatment can significantly improve the symptoms of Parkinson's disease(PD) and delay the progression of the disease. In order to further explore the effectiveness of rTMS in the treatment of PD and lay the foundation for its clinical promotion, our research team plans to conduct a randomized double-blind controlled study of rTMS in the treatment of PD in multiple centers across the country.

Подробное описание

This is a multi-center, double-blind, randomized controlled study that will be implemented in multiple hospital centers in China. In this study, the supplementary motor area (SMA) of the dominant hemisphere was selected as the stimulation target, and continuous theta burst stimulation (cTBS) sequence contact stimulation was used for a course of continuous stimulation for 7 days to observe the changes in clinical symptoms before and after the intervention.

Вмешательства

  • Другое transcranial magnetic stimulation
    The stimulations were performed by MagStim Rapid2.

Первичные конечные точки

  • Movement Disorder Society- Unified Parkinson's Disease Rating Scale III scores [Срок оценки: baseline; day 8; week 5;week 9]
Вторичные конечные точки (12)
  • Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅰ scores [Срок оценки: baseline; day 8; week 5;week 9]
  • Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅱ scores [Срок оценки: baseline; day 8; week 5;week 9]
  • Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅳ scores [Срок оценки: baseline; day 8; week 5;week 9]
  • Hoehn-Yahr(H-Y) scale [Срок оценки: baseline; day 8; week 5;week 9]
  • The timed up and go test (TUG) [Срок оценки: baseline; day 8; week 5;week 9]
  • 20 meters walking [Срок оценки: baseline; day 8; week 5;week 9]
  • Non-motor symptom scale（NMSS） [Срок оценки: baseline; day 8; week 5;week 9]
  • Parkinson's Disease questionnaire-39 items（PDQ-39） [Срок оценки: baseline; day 8; week 5;week 9]
  • Hamilton Depression Scale-17（HAMD-17） [Срок оценки: baseline; day 8; week 5;week 9]
  • Hamilton Anxiety Scale（HAMA） [Срок оценки: baseline; day 8; week 5;week 9]
  • Pittsburgh sleep quality index（PSQI） [Срок оценки: baseline; day 8; week 5;week 9]
  • Mini-Mental State Examination（MMSE） [Срок оценки: baseline; day 8; week 5;week 9]

Критерии участия

Критерии включения

  • Age ≥ 40 years old;
  • Meet the diagnostic criteria for idiopathic Parkinson's disease (MDS Diagnostic Criteria for Parkinson's Disease (2015 Edition))\[1\];
  • Have no history of drug adjustment within 4 weeks before treatment and the entire study period;
  • The MDS-UPDRS Ⅲ score ≥8, and the Hoehn-Yahr rating is 1-4;
  • MMSE ≥22，able to cooperate with the completion of behavioral tests and transcranial magnetic stimulation therapy.

Критерии исключения

  • Previously head MRI/CT was focal brain injury or severe leukoencephalopathy (Fazekas grade 3 and above);
  • Various secondary parkinsonism syndromes (vascular parkinsonism, Parkinsonism combined with parkinsonism, drug parkinsonism, etc.);
  • Severe craniocerebral trauma, received craniocerebral surgery or deep brain stimulation treatment;
  • There are ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.
  • The person has a history of epilepsy, unexplained loss of consciousness, or are taking anticonvulsant drugs to treat epileptic seizures;
  • Diagnosed with a neuropsychiatric disorder other than PD
  • Have a history of drug abuse or drug use;
  • Participants in any clinical trial within the previous 6 month;
  • Pregnant/lactating women or subjects (including men) who have a birth plan within 6 months;
  • Other conditions deemed unsuitable for inclusion by the investigator.

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
  • Cognitive Neuropsychology Lab Anhui Medical University — Хэфэй

Публикации

  • Chen X, Ji GJ, Ye R, Sun J, Hu L, Han J, Yu L, Li Y, Wu J, Zhu M, Cheng J, Liu P, Liu T, Sun L, Yuan J, Liang Z, Du J, Gong L, Zhang K, Sun H, Zhong P, Wang K, Hu P. The efficacy and safety of precision repetitive transcranial magnetic stimulation in alleviating motor symptoms in Parkinson's disease (PRESS-PD): a randomized, double-blind, multicenter, placebo-controlled trial. Trials. 2026 Mar 27; PMID 41896996

Идентификаторы

NCT: NCT06383247 · AMU-PD-multicenter

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗