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

ConditionParkinson's Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-70
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 40Hz light modulation glasses

    Device

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

  • 100Hz light modulation glasses

    Device

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

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Group1:40Hz flash stimulationExperimental treatment 1 intervention
Group B: Group2:100Hz flash stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Brain glymphatic function

The gBOLD-CSF coupling strength is improved in PD patients treated with 40Hz flash stimulation.

Time frame
The first day after treatment

Secondary outcomes

1

Movement Disorder Society Unified Parkinson's Disease Rating Scale （MDS-UPDRS）

MDS-UPDRS III score is decreased more than 3 points in PD patients treated with 40Hz flash stimulation.（The higher scores mean a worse outcome ）

Time frame
The first day after treatment
2

Parkinson's disease sleep scale（PDSS）

PDSS scale is decreased by more than 3 points in PD patients treated with 40Hz flash stimulation.（The higher scores mean a worse outcome ）

Time frame
The first day after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: