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

NCT07271927 | Recruiting

• 1 other identifier: 23-2024-005
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PARKINSON DISEASE (Disorder)

Keywords

Photobiomodulation; Parkinson disease; cognition; motor function; light theraphy

Outcome Measures

Primary Outcomes (1)

• UPDRS

  Unified Parkinson's Disease Rating Scale

  Change in UPDRS from baseline to post 30 sessions (up to approximately 10 weeks). The UPDRS ranges from 0 to 199, with higher scores indicating greater symptom severity.

Secondary Outcomes (10)

• BBS

  Change in Berg Balance Scale scores from baseline to post 30 sessions (up to approximately 10 weeks). The BBS ranges from 0 to 56, with higher scores indicating better balance performance.

• Grip strength and pinch strength test

  Change in Grip strength and pinch strength from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better hand function.

• FRT

  Change in Functional Reach Test scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better hand function.

• TUG

  Change in Timed Up and Go test scores from baseline to post 30 sessions (up to approximately 10 weeks). Lower scores indicate better functional mobility.

• CTRS

  Change in CRTS scores from baseline to post 30 sessions (up to approximately 10 weeks). The score ranges from 0 to 160, with higher scores indicating more severe tremor symptoms.

Study Arms (1)

Parkinson

EXPERIMENTAL

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

Device: Photobiomodulation

Interventions

Photobiomodulation DEVICE

Participants received whole-body PBM therapy over approximately 10 weeks (three sessions per week, once daily, 20 minutes per session), with each session using a randomly selected wavelength of either 660 nm, 850 nm, or 940 nm (±20%).

Parkinson

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Jisoo Baik

CONTACT

082+055-360-4159; zisoo@pusan.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: December 9, 2025
• Study Start: February 12, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)