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

NCT ID: NCT07271927

Last Updated: 2025-12-09

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-12

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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PARKINSON DISEASE (Disorder)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Parkinson

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

Group Type EXPERIMENTAL

Photobiomodulation

Intervention Type 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%).

Interventions

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Photobiomodulation

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%).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pusan National University Yangsan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yong-il Shin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jisoo Baik

Role: CONTACT

082+055-360-4159

Facility Contacts

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Youjin Jeong

Role: primary

+82-55-360-4720

Other Identifiers

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23-2024-005

Identifier Type: -

Identifier Source: org_study_id

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