Parkinson's DiseaseNCT06848621
A Single-blind, Randomized, Controlled Clinical Study of Flash Stimulation Therapy in Parkinson's Disease
A study testing 40Hz light modulation glasses and 100Hz light modulation glasses in people with Parkinson's Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- 40Hz light modulation glasses and 100Hz light modulation glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 31000
jiali pu, doctor
jun tian, doctor
About this study
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- 40Hz light modulation glasses, 100Hz light modulation glasses
- Keywords
- Parkinson's disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: 100Hz light modulation glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain glymphatic function
The gBOLD-CSF coupling strength is improved in PD patients treated with 40Hz flash stimulation.
Measured: The first day after treatment
Secondary outcomes (2)
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 ）
Measured: The first day after treatment
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 ）
Measured: The first day after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Baorong, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848621
- Sponsor's protocol ID
- 2024-1021
- Status last verified
- Jan 2025
- First submitted
- 4 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share the IPD when the article is published.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Randomized, Controlled Clinical Study of Flash Stimulation Therapy in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06848621
- Acronym / sponsor ID
- 2024-1021
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1:40Hz flash stimulation | Experimental | Device: 40Hz light modulation glassesA one-week 40HZ flash stimulation therapy (JK-PMEG2700K light modulation glasses [light source]) using flash stimulation between 20:00 and 21:00. |
| Group2:100Hz flash stimulation | Sham comparator | Device: 100Hz light modulation glassesA one-week 100HZ flash stimulation therapy (JK-PMEG2700K light modulation glasses [light source]) using flash stimulation between 20:00 and 21:00. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40Hz light modulation glassesA one-week flash stimulation therapy (JK-PMEG2700K light modulation glasses [light source]) using flash stimulation between 20:00 and 21:00. | Device | Group1:40Hz flash stimulation |
| 100Hz light modulation glassesA one-week flash stimulation therapy (JK-PMEG2700K light modulation glasses [light source]) using flash stimulation between 20:00 and 21:00. | Device | Group2:100Hz flash stimulation |
Primary outcome
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.
2 secondary outcomes
Movement Disorder Society Unified Parkinson's Disease Rating Scale （MDS-UPDRS）
Time frame: The first day after treatment
Parkinson's disease sleep scale（PDSS）
Time frame: The first day after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No. We will share the IPD when the article is published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 40Hz light modulation glasses and 100Hz light modulation glasses in people with Parkinson's Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact baorong zhang, Doctor (+86-13958167260, brzhang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain glymphatic function (time frame: The first day after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.