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Идёт набор NCT06542991

An Open-label Study on the Clinical Efficacy of rTMS Intervention in PD

Без фазы С лечением Transcranial Magnetic Stimulation Parkinson Disease 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: Transcranial Magnetic Stimulation, Parkinson Disease, 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
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Обзор

To demonstrate that intervention targeting the supplementary motor area (SMA) using precise navigation positioning can effectively improve motor symptoms in patients with Parkinson's disease.

Подробное описание

As an innovative non-invasive neuromodulation technology, repetitive transcranial magnetic stimulation (rTMS) has demonstrated efficacy in improving motor symptoms in patients with Parkinson's disease (PD). The supplementary motor area (SMA) has been identified as a brain region significantly associated with motor symptoms in PD patients. However, no large-sample clinical studies have yet established the clinical efficacy of rTMS, guided by neuroimaging navigation, targeting the SMA in patients with Parkinson's disease.

We describe a open-lable study designed to recruit 20 patients with idiopathic Parkinson's disease. Participants will be randomly assigned to receive either real stimulation or sham stimulation, with the left SMA undergoing 7 days of continuous theta burst stimulation (cTBS). The primary outcome measure is the change in the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scores from baseline to post-treatment and follow-up. Secondary outcomes include changes in scores on other clinical symptom scales.

Вмешательства

  • Другое transcranial magnetic stimulation
    During treatment, the patient underwent cTBS targeting the left SMA for 7 consecutive days. Each treatment day comprised six rounds of cTBS, with a 15-minute interval between each. A single cTBS session involved trains of three pulses at 50 Hz, repeated every 200 ms (5 Hz), until reaching a total of 600 pulses, lasting 40s. Stimulation intensity remained at 80% of resting motor threshold. In total, patients received 25,200 pulses throughout the treatment period.

Первичные конечные точки

  • Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale Part Ⅲ [Срок оценки: baseline; day 8; week 5;week 9;]
Вторичные конечные точки (2)
  • Hoehn-Yahr(H-Y) stage [Срок оценки: baseline; day 8; week 5;week 9;]
  • The timed up and go test [Срок оценки: baseline; day 8; week 5;week 9;]

Критерии участия

Критерии включения

  • Age ≥40 years old
  • Meet Movement Disorder Society standards;
  • Have no history of drug adjustment within 4 weeks before and during treatment;
  • The MDS-UPDRS Ⅲ score ≥8, and the Hoehn-Yahr rating is 1-4
  • MMSE ≥24，able to cooperate with the completion of behavioral tests and transcranial magnetic stimulation therapy.

Критерии исключения

  • Head MRI/CT ruled out focal brain injury or severe leukoencephalopathy (Fazekas grade 3);
  • 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 or first-degree relatives have 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
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Cognitive Neuropsychology Lab Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT06542991 · PD-OPEN

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗