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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06848621
Enrollment
48
Registered
2025-02-27
Start date
2025-03-01
Completion date
2026-12-31
Last updated
2025-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's disease

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.

Interventions

DEVICE40Hz 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.

DEVICE100Hz 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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Brain glymphatic functionThe first day after treatmentThe gBOLD-CSF coupling strength is improved in PD patients treated with 40Hz flash stimulation.

Secondary

MeasureTime frameDescription
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)The first day after treatmentMDS-UPDRS III score is decreased more than 3 points in PD patients treated with 40Hz flash stimulation.(The higher scores mean a worse outcome )
Parkinson's disease sleep scale(PDSS)The first day after treatmentPDSS scale is decreased by more than 3 points in PD patients treated with 40Hz flash stimulation.(The higher scores mean a worse outcome )

Countries

China

Contacts

Primary Contactbaorong zhang, Doctor
brzhang@zju.edu.cn+86-13958167260
Backup Contactyang ruan, Doctor
11818236@zju.edu.cn+86-18858736151

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026