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Идёт набор NCT06856941

CsDCS on Functional Mobility in Parkinsons Disease

Без фазы С лечением Parkinson 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: cerebello-spinal direct current stimulation, sham cerebello-spinal direct current stimulation.
Кому может быть актуально
Состояния в реестре: Parkinson Disease. 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
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Официальное название

Cerebello-spinal Direct Current Stimulation Associated with Treadmill Gait Training in Functional Mobility in Patients with Parkinsons Disease

Обзор

Parkinsons disease is a progressive neurological disorder marked by a decline in the efficacy of dopaminergic synapses in the nigrostriatal pathway, causing motor disturbances. Resting tremor, bradykinesia, and muscle rigidity are the most prominent motor features. These factors result in gait impairments, including slowness and freezing. The primary treatment for the disease is medication. However, while medication does reduce motor symptoms, prolonged usage may lead to an increase of dyskinesias and a worsening of a patients clinical condition. Thus, alternative therapies, such as cerebellospinal direct current stimulation (csDCS), have gained popularity. Studies suggest that csDCS may be an effective approach to mitigate gait disorders in this patient population. Kinesiotherapy is an established therapeutic method that has been demonstrated to promote functional mobility and improve gait. To date, the combination of kinesiotherapy and csDCS has not been tested, thus the purpose of this study is to evaluate the effectiveness of this combined therapy for enhancing functional mobility in Parkinsons disease patients. The goal of this study is to assess the efficacy of blending csDCS and kinesiotherapy for improving patients functional mobility in Parkinsons disease. Two groups of volunteers will be assigned: i) actual csDCS + kinesiotherapy, and ii) sham csDCS + kinesiotherapy. The full procedure involves 10 therapy sessions conducted across two weeks.

Вмешательства

  • Устройство cerebello-spinal direct current stimulation
    Cerebello-spinal direct current stimulation is an electrical stimulus in the cerebellum as well as in the spinal cord that is used to improve functional mobility. To our knowledge, this is the first study to use this setup in individuals with Parkinsons disease.
  • Устройство sham cerebello-spinal direct current stimulation
    Sham cerebello-spinal direct current stimulation involves masking, where the total duration of stimulation is thirty seconds, which is sufficient to mimic the sensation of stimulation but without neuromodulatory effects

Первичные конечные точки

  • Timed Up and Go [Срок оценки: From enrollment to the end of treatment at 4 weeks]
Вторичные конечные точки (5)
  • Five times sit to stand test [Срок оценки: From enrollment to the end of treatment at 4 weeks]
  • Mini balance evaluation system test [Срок оценки: From enrollment to the end of treatment at 4 weeks]
  • Unified Parkinson Disease Rating Scale-II and Scale-III [Срок оценки: From enrollment to the end of treatment at 4 weeks]
  • Freezing of gait questionnaire [Срок оценки: From enrollment to the end of treatment at 4 weeks]
  • Six minute walking test [Срок оценки: From enrollment to the end of treatment at 4 weeks]

Критерии участия

Критерии включения

  • a clinical diagnosis of PD provided by a neurologist
  • regular dopaminergic drug treatment (at least three months of use)
  • aged 40 years or over
  • staging I to IV on the modified Hoehn and Yahr scale

Критерии исключения

  • other neurological disorders, postural hypotension, vestibular, musculoskeletal or visual disorders that compromise performance in the proposed tests
  • other osteoarticular diseases in the lower limbs that interfere with performance and locomotion
  • a Montreal Cognitive Assessment (MoCA) score of less than 21 points
  • have undergone previous surgery for PD

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Бразилия · 1 центр
  • Universidade Federal de Pernambuco — Recife

Идентификаторы

NCT: NCT06856941 · 78055423.8.1001.5208

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗