Whole-Body Photobiomodulation for Motor and Cognitive Changes in Parkinson's Disease (PBM)

Pusan National University Yangsan Hospital

Status: Enrolling

Conditions: PARKINSON DISEASE (Disorder)

Treatments: Device: Photobiomodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07271927

23-2024-005

Details and patient eligibility

About

This study aims to exploratorily evaluate the extent of motor and cognitive changes, as well as the safety, resulting from approximately 10 weeks of whole-body photobiomodulation (PBM) therapy (about three sessions per week, once daily, 20 minutes per session) in patients with Parkinson's disease.

Enrollment: 15 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals diagnosed with Parkinson's disease at Hoehn and Yahr stages 1-3 based on medical history and examination
• Adults aged 40 years or older
• Individuals able to walk independently

Exclusion criteria

• Individuals with severe cognitive impairment (Korean Mini-Mental State Examination [K-MMSE] score ≤ 9) making it difficult to understand and perform tasks
• Patients with dementia other than Parkinson's disease dementia
• Individuals with implanted medical or other electronic devices
• Individuals with severe neuropsychiatric disorders
• Individuals treated for alcohol dependence within 6 months prior to screening
• Individuals with a history of suicide attempts
• Individuals with a history of seizures
• Individuals experiencing dyspnea while sitting at rest
• Individuals with visual impairment preventing them from reading ordinary text even with corrective lenses
• Individuals with hearing impairment preventing them from understanding conversation even with a hearing aid
• Individuals who have participated in two or more clinical trials in the same year or in another clinical trial within the past 6 months
• Women and men of childbearing potential who are planning pregnancy during the trial or who do not agree to use appropriate contraceptive methods
• Pregnant or breastfeeding women
• Individuals deemed medically inappropriate for participation by the principal investigator or study staff based on clinically significant findings not otherwise specified above

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Parkinson

Experimental group

Description:

Participants received whole-body PBM therapy once daily (20 minutes per session), three times per week, for approximately 10 weeks, totaling 30 sessions.

Treatment:

Device: Photobiomodulation