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Идёт набор NCT07271927

Whole-Body Photobiomodulation for Motor and Cognitive Changes in Parkinson's Disease

Без фазы С лечением PARKINSON DISEASE (Disorder)

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: Photobiomodulation.
Кому может быть актуально
Состояния в реестре: PARKINSON DISEASE (Disorder). 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
South Korea
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

Evaluation Study of the Effects and Safety of Whole-Body Photobiomodulation Therapy on Motor and Cognitive Changes in Patients With Parkinson's Disease

Обзор

This study aims to exploratorily evaluate the extent of motor and cognitive changes, as well as the safety, resulting from approximately 10 weeks of whole-body photobiomodulation (PBM) therapy (about three sessions per week, once daily, 20 minutes per session) in patients with Parkinson's disease.

Вмешательства

  • Устройство Photobiomodulation
    Participants received whole-body PBM therapy over approximately 10 weeks (three sessions per week, once daily, 20 minutes per session), with each session using a randomly selected wavelength of either 660 nm, 850 nm, or 940 nm (±20%).

Первичные конечные точки

  • UPDRS [Срок оценки: Change in UPDRS from baseline to post 30 sessions (up to approximately 10 weeks). The UPDRS ranges from 0 to 199, with higher scores indicating greater symptom severity.]
Вторичные конечные точки (10)
  • BBS [Срок оценки: Change in Berg Balance Scale scores from baseline to post 30 sessions (up to approximately 10 weeks). The BBS ranges from 0 to 56, with higher scores indicating better balance performance.]
  • Grip strength and pinch strength test [Срок оценки: Change in Grip strength and pinch strength from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better hand function.]
  • FRT [Срок оценки: Change in Functional Reach Test scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better hand function.]
  • TUG [Срок оценки: Change in Timed Up and Go test scores from baseline to post 30 sessions (up to approximately 10 weeks). Lower scores indicate better functional mobility.]
  • CTRS [Срок оценки: Change in CRTS scores from baseline to post 30 sessions (up to approximately 10 weeks). The score ranges from 0 to 160, with higher scores indicating more severe tremor symptoms.]
  • SVLT [Срок оценки: Change in SVLT scores from baseline to post 30 sessions (up to approximately 10 weeks). The scores ranging from 0 to 36, where higher scores reflect better memory performance.]
  • RCFT [Срок оценки: Change in RCFT scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better visuospatial and memory performance.]
  • DST [Срок оценки: Change in DST scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better performance.]
  • TMT [Срок оценки: Change in TMT scores from baseline to post 30 sessions (up to approximately 10 weeks). Faster completion times (i.e., lower scores) indicate better cognitive function.]
  • K-CWST [Срок оценки: Change in K-CWST scores from baseline to post 30 sessions (up to approximately 10 weeks). Faster completion times (i.e., lower scores) indicate better cognitive function.]

Критерии участия

Критерии включения

  • Individuals diagnosed with Parkinson's disease at Hoehn and Yahr stages 1-3 based on medical history and examination
  • Adults aged 40 years or older
  • Individuals able to walk independently

Критерии исключения

  • Individuals with severe cognitive impairment (Korean Mini-Mental State Examination \[K-MMSE\] score ≤ 9) making it difficult to understand and perform tasks
  • Patients with dementia other than Parkinson's disease dementia
  • Individuals with implanted medical or other electronic devices
  • Individuals with severe neuropsychiatric disorders
  • Individuals treated for alcohol dependence within 6 months prior to screening
  • Individuals with a history of suicide attempts
  • Individuals with a history of seizures
  • Individuals experiencing dyspnea while sitting at rest
  • Individuals with visual impairment preventing them from reading ordinary text even with corrective lenses
  • Individuals with hearing impairment preventing them from understanding conversation even with a hearing aid
  • Individuals who have participated in two or more clinical trials in the same year or in another clinical trial within the past 6 months
  • Women and men of childbearing potential who are planning pregnancy during the trial or who do not agree to use appropriate contraceptive methods
  • Pregnant or breastfeeding women
  • Individuals deemed medically inappropriate for participation by the principal investigator or study staff based on clinically significant findings not otherwise specified above

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

South Korea · 1 центр
  • Pusan National University Yangsan Hospital — Yangsan

Идентификаторы

NCT: NCT07271927 · 23-2024-005

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗