PARKINSON DISEASE (Disorder)PBMNCT07271927
Whole-Body Photobiomodulation for Motor and Cognitive Changes in Parkinson's Disease
A study testing Photobiomodulation in people with PARKINSON DISEASE (Disorder), run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Feb 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
Youjin Jeong, +82-55-360-4720, gamza33@naver.com
About this study
Official title: Evaluation Study of the Effects and Safety of Whole-Body Photobiomodulation Therapy on Motor and Cognitive Changes in Patients With Parkinson's Disease
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)
- Being tested
- Photobiomodulation
- Keywords
- Photobiomodulation, Parkinson disease, cognition, motor function, light theraphy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
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%).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS
Unified Parkinson's Disease Rating Scale
Measured: 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
Berg Balance Scale
Measured: 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
Grasp, tip pinch \& three jaw chuck
Measured: 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
Functional Reach Test
Measured: Change in Functional Reach Test scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better hand function.
TUG
Timed Up and Go
Measured: 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
Clinical Rating Scale for Tremor
Measured: 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.
SVLT
Seoul verbal learning test
Measured: Change in SVLT scores from baseline to post 30 sessions (up to approximately 10 weeks). The scores ranging from 0 to 36, where higher scores reflect better memory performance.
RCFT
Rey complex figure test
Measured: Change in RCFT scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better visuospatial and memory performance.
DST
Digit span test
Measured: Change in DST scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better performance.
TMT
Trail making test
Measured: Change in TMT scores from baseline to post 30 sessions (up to approximately 10 weeks). Faster completion times (i.e., lower scores) indicate better cognitive function.
K-CWST
Korean-Color word stroop test
Measured: Change in K-CWST scores from baseline to post 30 sessions (up to approximately 10 weeks). Faster completion times (i.e., lower scores) indicate better cognitive function.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start12 Feb 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong-il Shin, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271927
- Sponsor's protocol ID
- 23-2024-005
- Acronym
- PBM
- Status last verified
- Nov 2025
- First submitted
- 21 Aug 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) cannot be shared due to protection of participants' personal information and regulatory restrictions of our hospital.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Study of the Effects and Safety of Whole-Body Photobiomodulation Therapy on Motor and Cognitive Changes in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07271927
- Acronym / sponsor ID
- PBM / 23-2024-005
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- Photobiomodulation, Parkinson disease, cognition, motor function, light theraphy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson | Experimental | Device: PhotobiomodulationParticipants received whole-body PBM therapy once daily (20 minutes per session), three times per week, for approximately 10 weeks, totaling 30 sessions. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationParticipants 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%). | Device | Parkinson |
Primary outcome
UPDRS
Time frame: 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.
Unified Parkinson's Disease Rating Scale
10 secondary outcomes
BBS
Time frame: 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
Time frame: 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
Time frame: Change in Functional Reach Test scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better hand function.
TUG
Time frame: 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
Time frame: 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.
SVLT
Time frame: Change in SVLT scores from baseline to post 30 sessions (up to approximately 10 weeks). The scores ranging from 0 to 36, where higher scores reflect better memory performance.
RCFT
Time frame: Change in RCFT scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better visuospatial and memory performance.
DST
Time frame: Change in DST scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better performance.
TMT
Time frame: Change in TMT scores from baseline to post 30 sessions (up to approximately 10 weeks). Faster completion times (i.e., lower scores) indicate better cognitive function.
K-CWST
Time frame: Change in K-CWST scores from baseline to post 30 sessions (up to approximately 10 weeks). Faster completion times (i.e., lower scores) indicate better cognitive function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) cannot be shared due to protection of participants' personal information and regulatory restrictions of our hospital.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with PARKINSON DISEASE (Disorder), run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jisoo Baik (082+055-360-4159, zisoo@pusan.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPDRS (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.