A Single-blind, Randomized, Controlled Clinical Study of Flash Stimulation Therapy in Parkinson's Disease
NCT ID: NCT06848621
Last Updated: 2025-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
48 participants
INTERVENTIONAL
2025-03-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
50 Years
70 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Zhang Baorong
Chief physician
Locations
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The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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2024-1021
Identifier Type: -
Identifier Source: org_study_id
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