Clinical trial NCT06848621: A Single-blind, Randomized, Controlled Clinical Study of Flash Stimulation Therapy in Parkinson's Disease
Official title: A Single-blind, Randomized, Controlled Clinical Study of Flash Stimulation Therapy in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson&#39;s Disease
Keywords: Parkinson&#39;s disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. Anti-PD drugs were taken regularly for at least one month before screening, and symptoms were stable;
3. 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;
4. Have the ability to understand and voluntarily sign informed consent;
5. Have good compliance and are willing to complete all follow-up required by this program.

Exclusion Criteria:

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

Primary outcomes:
measure: Brain glymphatic function
timeFrame: The first day after treatment
Secondary outcomes:
measure: Movement Disorder Society Unified Parkinson's Disease Rating Scale （MDS-UPDRS）
timeFrame: The first day after treatment
measure: Parkinson's disease sleep scale（PDSS）
timeFrame: The first day after treatment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: