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

February 21, 2025 updated by: Zhang Baorong, Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 31000
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
          • jiali pu, doctor
        • Contact:
          • jun tian, doctor
        • Contact:
          • yang ruan, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group1:40Hz flash stimulation
A one-week 40HZ flash stimulation therapy (JK-PMEG2700K light modulation glasses [light source]) using flash stimulation between 20:00 and 21:00.
Device: 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.
Sham Comparator: Group2:100Hz flash stimulation
A one-week 100HZ flash stimulation therapy (JK-PMEG2700K light modulation glasses [light source]) using flash stimulation between 20:00 and 21:00.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The first day after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 ）
The first day after treatment
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 ）
The first day after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-1021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will share the IPD when the article is published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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