Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06848621

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 31000, China

Location contact

jiali pu, doctor

SUB_INVESTIGATOR

jun tian, doctor

SUB_INVESTIGATOR

yang ruan, doctor

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Brain glymphatic function

    Time frame: The first day after treatment

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

Secondary outcomes

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

    Time frame: The first day after treatment

    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 )

  2. Parkinson's disease sleep scale(PDSS)

    Time frame: The first day after treatment

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

Study contacts

Contact information is provided by the study sponsor or research team.

baorong zhang, Doctor

CONTACT

[email protected]

+86-13958167260

yang ruan, Doctor

CONTACT

[email protected]

+86-18858736151

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.