Меню
Идёт набор NCT07488026

Effects of the Stimulation Site of tsMS With TMS on Functional Mobility in Individuals With Parkinson's Disease

Без фазы С лечением Parkinson's Disease (PD) Gait Disorders Transcranial Magnetic Stimulation Spinal Cord Stimulation

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: Repetitive Transcranial Magnetic Stimulation, Cervical Trans-spinal Magnetic Stimulation, Thoracic Trans-spinal Magnetic Stimulation.
Кому может быть актуально
Состояния в реестре: Parkinson's Disease (PD), Gait Disorders, Transcranial Magnetic Stimulation, Spinal Cord Stimulation. 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
Бразилия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Effects of the Stimulation Site of Trans-spinal Magnetic Stimulation Combined With Transcranial Magnetic Stimulation on Functional Mobility in Individuals With Parkinson's Disease

Обзор

This randomized clinical trial aims to compare the effects of two different trans-spinal magnetic stimulation (tsMS) application sites, cervical versus thoracic, when combined with repetitive transcranial magnetic stimulation (rTMS), on functional mobility in individuals with Parkinson's disease (PD). Participants diagnosed with PD will be randomized into two intervention groups (rTMS + cervical tsMS or rTMS + thoracic tsMS) and will undergo 10 treatment sessions. Outcomes will include functional mobility, gait speed, motor function, freeing of gait, balance, quality of life, global perceived improvement and adverse events. The study is expected to identify the most effective tsMS application site to enhance mobility and motor outcomes in PD, contributing to the optimization and standardization of tsMS protocols as an adjunct therapy.

Вмешательства

  • Устройство Repetitive Transcranial Magnetic Stimulation
    Repetitive transcranial magnetic stimulation applied over the primary motor cortex using standardized stimulation parameters.
  • Устройство Cervical Trans-spinal Magnetic Stimulation
    Trans-spinal magnetic stimulation applied at the cervical level using standardized stimulation parameters.
  • Устройство Thoracic Trans-spinal Magnetic Stimulation
    Trans-spinal magnetic stimulation applied at the thoracic level using standardized stimulation parameters.

Первичные конечные точки

  • Functional Mobility (Timed Up and Go Test) [Срок оценки: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention]
Вторичные конечные точки (8)
  • Statatic and Dynamic Balance (Mini Balance Evaluation Systems Test - MiniBESTest) [Срок оценки: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention]
  • Motor function (Movement Disorder Society-Unified Parkinson's Disease Rating Scale - MDS-UPDRS) [Срок оценки: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention]
  • Freezing of gait (Freezing of gait Questionnaire - FOG-Q) [Срок оценки: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention]
  • Gait speed (10 meter-walk test) [Срок оценки: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention]
  • Lower limb stength (Five times sit-to-stand test) [Срок оценки: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention]
  • Quality of Life Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39): Total Score and Domain Scores [Срок оценки: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention]
  • Global Perceived Improvement (Global perceived change scale) [Срок оценки: At Day 10 (end of intervention)]
  • Adverse events [Срок оценки: Throughout the intervention period (10 days)]

Критерии участия

Inclusion Criteria: (i) a clinical diagnosis of Parkinson's disease confirmed by a neurologist; (ii) stable dopaminergic pharmacological treatment for at least three months; (iii) age 40 years or older; (iv) disease stage between 2.5 and 3 on the modified Hoehn and Yahr scale; (v) (v) gait impairment, defined as the occurrence of at least one freezing of gait episode per week.

\-

Критерии исключения

(i) other neurological disorders, orthostatic hypotension, vestibular, musculoskeletal, or visual impairments that could compromise performance on the proposed assessments; (ii) other osteomuscular conditions affecting the lower limbs that interfere with mobility and functional performance; (iii) a Montreal Cognitive Assessment (MoCA) score lower than 21 points; (iv) prior surgical procedures for Parkinson's disease; or (v) contraindications to magnetic stimulation techniques, including a history of seizures or the presence of metallic implants in the neck or spinal region.

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

Бразилия · 1 центр
  • Universidade Federal de Pernambuco — Recife

Идентификаторы

NCT: NCT07488026 · TMS_tsMS_DP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗