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Safety Study of Non-invasive Modulation of Meningeal Lymphatics by Light

Safety Study of Non-invasive Modulation of Meningeal Lymphatics by Light

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116786
Enrollment
Unknown
Registered
2026-01-15
Start date
2026-01-15
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Elderly Cohort:Photobiomodulation therapy
Youth Group (Experimental Group):The transcranial light therapy will be carried out using an LED light therapy cap.
Youth Group (Control Group):Received the same surface treatment as the control group, but the equipment used was a fake transcranial LED device, which did not emit any light.

Sponsors

The Second Affiliated Hospital of Hainan Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age between 18 years and 30 years old, or between 60 years and 80 years old, gender not restricted; 2. The patient fully understands the purpose and requirements of this trial, voluntarily participates in the clinical trial and signs a written informed consent form, and is willing to complete all the trial procedures as required.

Exclusion criteria

Exclusion criteria: Subjects meeting ?any? of the following criteria will be excluded: 1.Concomitant severe systemic diseases? (e.g., heart failure, respiratory failure, hepatic/renal impairment, immune deficiency, malignant tumors) 2.History of neurological/psychiatric disorders? including: Cerebrovascular events (stroke), traumatic brain injury, epilepsy Neurodegenerative diseases (Parkinson's disease, parkinsonism, Alzheimer's disease, motor neuron disease) Severe psychiatric disorders (anxiety disorders, major depression, schizophrenia) 3.Investigator-determined unsuitability? for trial participation 4.Current use of photosensitizing medications?: Imipramine, St. John's wort, ?phenothiazines?, lithium, chloroquine, hydrochlorothiazide, tetracyclines

Design outcomes

Primary

MeasureTime frame
Adverse Event (AE) Incidence Rate;Changes in biomarkers of nerve injury;

Secondary

MeasureTime frame
The changes in electroencephalogram (EEG) compared to the baseline after 2 weeks of treatment (in the elderly group);Monitoring the changes in cerebral cortical oxygen saturation before and after treatment (in the elderly group);Monitor the change in MMSE score compared to the baseline after 2 weeks of treatment (in the elderly group);Changes in heart rate and pulse oximetry compared to the baseline after 2 weeks of treatment (in the elderly group);The change in the deep sleep rate after 2 weeks of treatment compared to the baseline (in the elderly group);The changes in electroencephalogram (EEG) compared to the baseline after 2 weeks of treatment (in the young group);Monitoring the changes in cerebral cortical oxygen saturation before and after treatment (in the young group);The changes in the n-back test after 2 weeks of treatment compared to the baseline (in the young group);Changes in heart rate and pulse oximetry compared to the baseline after 2 weeks of treatment (in the young group);The change in the deep sleep rate after 2 weeks of treatment compared to the baseline (in the young group);

Countries

China

Contacts

Public ContactYou Yong

The Second Affiliated Hospital of Hainan Medical University

hy213440@muhn.edu.cn+86 898 6680 9329

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026