UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062815 |
|---|---|
| Receipt number | R000071908 |
| Scientific Title | Changes in Cognition and Functional Brain Connectivity Associated with Transcranial Photobiomodulation in Older Adults: A Pilot Pre-Post Study |
| Date of disclosure of the study information | 2026/09/07 |
| Last modified on | 2026/09/03 21:35:21 |
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Basic information
Public title
Cognitive and EEG changes after 4 weeks of transcranial photobiomodulation in community-dwelling older adults: a single-arm pilot study
Acronym
tPBM cognition and EEG pilot
Scientific Title
Changes in Cognition and Functional Brain Connectivity Associated with Transcranial Photobiomodulation in Older Adults: A Pilot Pre-Post Study
Scientific Title:Acronym
tPBM cognition and EEG pilot
Region
| Japan |
Condition
Condition
Age-related cognitive decline in community-dwelling older adults (no clinical diagnosis required)
Classification by specialty
| Neurology | Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore changes in cognitive function (MoCA) and multi-level resting-state EEG measures (sensor-level spectral ratios, sLORETA source-level power, functional connectivity, and graph-theory network topology) following a 4-week course of transcranial photobiomodulation (tPBM) in community-dwelling older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in Montreal Cognitive Assessment (Japanese version 8.3) total score from baseline (1 day before the first tPBM session) to follow-up (1 day after the final session).
Key secondary outcomes
1. Sensor-level resting-state EEG power ratios (theta/beta2 ratio, delta/alpha ratio) by lobe region (frontal, central, temporal, parietal, occipital) 2. Source-level (sLORETA) delta/alpha ratio and alpha1 relative power in 22 a priori default-mode-network regions of interest 3. Functional connectivity (imaginary part of coherency) at global, regional, lobe, and ROI levels 4. Graph-theory network topology metrics (global efficiency, characteristic path length, clustering coefficient, small-worldness; ROI-level local metrics) 5. MoCA subdomain scores 6. Safety: adverse events reported during or after tPBM sessions
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Transcranial photobiomodulation (tPBM) with the iSyncWave wireless 19-channel EEG/tPBM headset (iMediSync Inc., Seoul, Republic of Korea)
GaAlAs LED (Everlight HIR383C/L289),one per site peak wavelength 850nm pulsed at 12Hz, 50% duty cycle; drive current 10mA (radiant intensity 70mW/sr)
All 19 electrode positions of the International 10/20 system (Fp1,Fp2,F7,F3,Fz,F4,F8,T3,C3,Cz,C4,T4,T5,P3,Pz,P4,T6,O1,O2), stimulated simultaneously
15 minutes; approximately 3.47J per site (65.9J total); estimated scalp irradiance 44.8mW/cm2 during the pulse on-phase (22.4mW/cm2 time/averaged); radiant exposure approximately 20J/cm2 per site per session.3 sessions per week for 4 weeks (12 sessions; 180 minutes total); cumulative dose approximately 41.6 J per site (790.6 J total)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Able to communicate and travel independently for daily living and study visits; (2) at least high-school education; (3) able to understand and complete the Japanese MoCA (version 8.3). No baseline MoCA cutoff was applied.
Key exclusion criteria
(1) History of neurological or brain parenchymal disease with current functional impairment (e.g., stroke, tumor, trauma, dementia, Parkinson disease), ascertained from documented medical history and functional status; (2) history of major psychiatric disorders.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Morihiro |
| Middle name | |
| Last name | Tsujishita |
Organization
Naragakuen University
Division name
Department of Rehabilitation, Faculty of Health Sciences
Zip code
6310003
Address
3-15-1, nakatomigaoka,Nara
TEL
0742-93-5431
tuzisita@nara-su.ac.jp
Public contact
Name of contact person
| 1st name | Morihiro |
| Middle name | |
| Last name | Tsujishita |
Organization
Naragakuen University
Division name
Department of Rehabilitation, Faculty of Health Sciences
Zip code
6310003
Address
3-15-1, nakatomigaoka,Nara
TEL
0742-93-5431
Homepage URL
tuzisita@nara-su.ac.jp
Sponsor or person
Institute
Naragakuen University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Naragakuen University
Address
3-15-1, nakatomigaoka,Nara
Tel
0742-93-5431
tuzisita@nara-su.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
18
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 02 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 03 | Day |
Last modified on
| 2026 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071908
