NCT06848621

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Mar 2025Dec 2026

First Submitted

Initial submission to the registry

February 4, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 27, 2025

Status Verified

January 1, 2025

Enrollment Period

1.8 years

First QC Date

February 4, 2025

Last Update Submit

February 21, 2025

Conditions

Parkinson's Disease

Keywords

Parkinson's disease

Outcome Measures

Primary Outcomes (1)

  • Brain glymphatic function

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

    The first day after treatment

Secondary Outcomes (2)

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

    The first day after treatment

  • Parkinson's disease sleep scale（PDSS）

    The first day after treatment

Study Arms (2)

Group1:40Hz flash stimulation

EXPERIMENTAL

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

Group2:100Hz flash stimulation

SHAM COMPARATOR

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

Interventions

40Hz light modulation glassesDEVICE

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

Group1:40Hz flash stimulation
100Hz light modulation glassesDEVICE

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

Group2:100Hz flash stimulation

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 31000, China

Location

Central Study Contacts

baorong zhang, Doctor

CONTACT

+86-13958167260brzhang@zju.edu.cn

yang ruan, Doctor

CONTACT

+86-1885873615111818236@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 27, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

We will share the IPD when the article is published.

Locations

CN(1)