Tokyo, Sept. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062815) titled 'Cognitive and EEG changes after 4 weeks of transcranial photobiomodulation in community-dwelling older adults: a single-arm pilot study' on Sept. 7.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Naragakuen University

Condition: Condition - Age-related cognitive decline in community-dwelling older adults (no clinical diagnosis required) Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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)

Eligibility: Age-lower limit - 60 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 Size - 20

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071908

Disclaimer: Curated by HT Syndication.