A Single-blind, Randomized, Controlled Clinical Study of Flash Stimulation Therapy in Parkinson's Disease

Обзор

The aim of this study was to evaluate the effect of flash stimulation therapy on the function of the cerebral glymphatic system and efficacy of improving symptoms in PD patients.

Подробное описание

Each subject will receive EEG recordings for two consecutive nights starting at 21:00. Participants will undergo baseline functional magnetic resonance imaging (fMRI). Subsequently, one week of flash stimulation therapy (JK-PMEG2700K light modulation glasses \[light source\]) was started, using flash stimulation between 20:00 and 21:00. After the 7-day flash stimulation treatment, a second round of clinical evaluation and fMRI will be performed.

Вмешательства

• Устройство 40Hz light modulation glasses
  A one-week flash stimulation therapy (JK-PMEG2700K light modulation glasses \[light source\]) using flash stimulation between 20:00 and 21:00.
• Устройство 100Hz light modulation glasses
  A one-week flash stimulation therapy (JK-PMEG2700K light modulation glasses \[light source\]) using flash stimulation between 20:00 and 21:00.

Первичные конечные точки

• Brain glymphatic function [Срок оценки: The first day after treatment]

Вторичные конечные точки (2)

• Movement Disorder Society Unified Parkinson's Disease Rating Scale （MDS-UPDRS） [Срок оценки: The first day after treatment]
• Parkinson's disease sleep scale（PDSS） [Срок оценки: The first day after treatment]

Критерии участия

Критерии включения

• PD patients who meet the diagnostic criteria of the International Movement Disorders Association (MDS), between the ages of 50 and 70 years, the course of disease ≤5 years, and the Hoehn \& Yahr stage ≤3;
• Anti-PD drugs were taken regularly for at least one month before screening, and symptoms were stable;
• The fixed bedtime in the past month is between 9:00 p.m. and 1:00 a.m., and the total sleep time is ≥6 hours;
• Have the ability to understand and voluntarily sign informed consent;
• Have good compliance and are willing to complete all follow-up required by this program.

Критерии исключения

• Secondary insomnia: including sleep disorders (restless leg syndrome, periodic limb movement disorder, sleep-related breathing disorders, etc.), physical diseases, mental disorders, psychoactive substance abuse;
• suffering from photosensitive dermatitis, epilepsy and other diseases that are not suitable for flash stimulation;
• Alcohol, coffee, or drug abusers in the past 6 months;
• Mental illness: such as anxiety, depression, schizophrenia and post-traumatic stress disorder caused by insomnia;
• Used drugs or health products that regulate sleep function or affect sleep within 14 days before enrollment or less than 5 drug half-lives;
• Taking drugs that may impair cognitive ability, such as anticholinergic drugs, memory enhancing drugs, etc., within 7 days before enrollment;
• the subject is unable to complete the test or follow-up;
• suffering from other neurodegenerative diseases;
• There are endoplants in the body that cannot be examined by MRI;
• Inability to lie flat;
• Other situations in which the researcher considers it inappropriate to participate in the study.

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

• The Second Affiliated Hospital of Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT06848621 · 2024-1021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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