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Clinical Study on the Safety and Efficacy of Non-invasive Phototherapy Targeting Meningeal Lymphatic Vessels in Parkinson's Disease

Clinical Study on the Safety and Efficacy of Non-invasive Phototherapy Targeting Meningeal Lymphatic Vessels in Parkinson's Disease

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113042
Enrollment
Unknown
Registered
2025-11-24
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Parkinson's disease

Interventions

Parkinson's disease group:Photobiomodulation

Sponsors

The Second Affiliated Hospital of Hainan Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. At the time of signing the informed consent, age between 18 and 90 years old, no gender restrictions; 2. Diagnosis meets the MDT clinical diagnostic criteria for Parkinson's disease, with no absolute exclusion criteria; 3. H&Y stage 1-3 (early stage); 4. Stable use of anti-PD medication for more than 1 month; 5. The patient fully understands the purpose and requirements of this trial, voluntarily participates in the clinical trial and signs the written informed consent, and is willing to complete the entire trial process as required.

Exclusion criteria

Exclusion criteria: 1. Severe systemic diseases, such as: heart failure, respiratory failure, liver or kidney dysfunction, immune deficiency, malignant tumors; 2. Secondary Parkinson's syndrome caused by other secondary factors (including: thyroid dysfunction, vitamin B12 and folic acid deficiency, traumatic brain injury, cerebral infarction/hemorrhage); 3. Parkinson's overlap syndromes (such as: PSA, MSA, DLB); 4. H&Y stage = stage 4 (advanced stage); 5. Comorbidities including severe heart disease, severe joint disease or orthopedic injury, peripheral neuropathy, vascular obstruction, severe musculoskeletal disorders, or vestibular dysfunction; 6. Considered by the investigator as unsuitable for participation in this trial; 7. Psychiatric episodes or suicidal ideation in the past 12 months; 8. Conditions that may affect PBM efficacy, such as structural brain disease, epilepsy, or use of potential photosensitive drugs (imipramine, St. John's wort, phenothiazines, lithium, chloroquine, hydrochlorothiazide, tetracycline).

Design outcomes

Primary

MeasureTime frame
DTI-ALPS index on cranial MRI;

Secondary

MeasureTime frame
Motor Function (MDS-UPDRS-III);Gait (TUG);Cognitive Function (MOCA, MMSE);Quality of Life (PDQ-39);Sleep Quality (Parkinson's Disease Sleep Scale, PDSS);Biomarkers of Neurodegenerative Diseases (such as peripheral blood P-tau217, Aß42/Aß40 ratio, p-tau181, GFAP, and NfL);Eye Movements;

Countries

China

Contacts

Public ContactYong You

The Second Affiliated Hospital of Hainan Medical University

hy213440@muhn.edu.cn+86 189 7699 1618

Outcome results

None listed

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