Effects of Photobiomodularion on Brain Connectivity and Cognitive Function in Cognitive Impairment

NCT07287527 | Recruiting FDA Device

• 1 other identifier: UUBAYP-2024-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to learn if transcranial photobiomodulation (t-PBM), a light-based brain therapy, can help improve memory and cognitive skills in older adults with amnestic mild cognitive impairment (aMCI). This condition involves memory problems that are greater than normal aging and may increase the chance of developing Alzheimer's disease. The main questions this study aims to answer are:

• Provide a blood sample so the research team can create a genetic profile;
• Complete cognitive tests before and after the 4-week program;
• Meet with a dietitian before and after the program so the research team can make sure diet stays consistent and does not influence brain results;
• Have a brain fMRI scan before and after treatment to measure brain connectivity changes;
• Take part in eight sessions of cognitive training;
• Receive either active t-PBM or sham t-PBM during these sessions.

Conditions

AMCI - Amnestic Mild Cognitive Impairment

Keywords

t-PBM; aMCI; fMRI; Cognitive Rehabilitation; functional connectivity; APOE; COMT

Outcome Measures

Primary Outcomes (2)

• Change in Default Mode Network (DMN) Functional Connectivity Measured by Resting-State fMRI

  Baseline and after completion of the 8-session intervention (approximately 4 weeks)

• Change in Montreal Cognitive Assessment (MoCA) Total Score

  Baseline and post-intervention cognitive performance will be compared using the Montreal Cognitive Assessment (MoCA), a standardized cognitive screening instrument. Score range: 0 to 30 points (higher scores indicate better cognitive performance).

  From baseline to post-intervention assessment following 8 sessions

Secondary Outcomes (1)

• Genotype-Based Comparison of Treatment Outcomes

  Baseline genetic assessment and post-intervention outcomes after completion of 8 sessions

Study Arms (2)

Intervention Arm: Active Treatment

EXPERIMENTAL

Participants in this arm will receive active transcranial photobiomodulation delivered at gamma frequency while simultaneously participating in a structured cognitive rehabilitation session. The photobiomodulation device will be placed on the participant's head and will operate continuously for 20 minutes during each session. Cognitive rehabilitation tasks will be administered throughout the stimulation period to enhance cognitive engagement. This combined intervention will be applied across all scheduled treatment sessions.

Device: Active transcranial Photobiomodulation; Behavioral: Cognitive Rehabilitation

Control Arm: Sham/Placebo

SHAM COMPARATOR

Participants in this arm will receive sham transcranial photobiomodulation while completing the same cognitive rehabilitation session provided to the experimental group. The device will be placed on the participant's head and will appear to operate normally; however, no active light output will be delivered. Each session lasts 20 minutes, during which participants complete standardized cognitive rehabilitation tasks. Session frequency, duration, and rehabilitation procedures are identical to the experimental arm to maintain blinding and ensure comparable conditions.

Device: sham transcranial Photobiomodulation; Behavioral: Cognitive Rehabilitation

Interventions

Active transcranial Photobiomodulation DEVICE

The active intervention consists of transcranial photobiomodulation (t-PBM) delivered while the device is placed on the participant's head and operating at gamma-frequency. The device provides active near-infrared light output throughout the 20-minute session. Active intervention is administered for a total of 8 sessions.

Intervention Arm: Active Treatment

sham transcranial Photobiomodulation DEVICE

The sham intervention uses the same transcranial photobiomodulation (t-PBM) device and head placement as the active intervention; however, no therapeutic near-infrared light output is delivered. The device's external indicators remain active to mimic real stimulation and maintain participant blinding. Each session lasts 20 minutes. The sham intervention is administered for a total of 8 sessions.

Control Arm: Sham/Placebo

Cognitive Rehabilitation BEHAVIORAL

The cognitive rehabilitation program consists of 8 sessions, each lasting 20 minutes, delivered simultaneously with either active or sham transcranial photobiomodulation (t-PBM). The program is a pen-and-paper-based cognitive exercise protocol targeting attention, memory, executive functions, and language. Each session includes structured tasks with predefined difficulty levels. Task difficulty increases progressively by 0.5 points from Session 1 onward, ensuring gradual cognitive challenge and adaptation across all eight sessions. The rehabilitation protocol is identical for both study arms.

Control Arm: Sham/Placebo; Intervention Arm: Active Treatment

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55 years or older
• Diagnosis of amnestic Mild Cognitive Impairment (aMCI)

You may not qualify if:

• Presence of a neurological disorder
• Presence of a severe psychiatric disorder
• Having a pacemaker or other implanted medical device that is not MRI-compatible

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (2)

NPIstanbul Brain Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Uskudar University, Faculty of Medicine

Istnabul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Chan AS, Lee TL, Hamblin MR, Cheung MC. Photobiomodulation Enhances Memory Processing in Older Adults with Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy Study. J Alzheimers Dis. 2021;83(4):1471-1480. doi: 10.3233/JAD-201600.

  PMID: 33998541 BACKGROUND

MeSH Terms

Interventions

Cognitive Training

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Baris Metin, Prof. Dr.

  Uskudar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shams Farhad, PhD

CONTACT

+905528566917; shams.farhad@uskudar.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants and their caregivers were masked to whether they received active t-PBM or sham stimulation. The clinician who diagnosed and referred participants into the study was also masked to group assignment. The sham procedure produced the same visual cues and procedures as active t-PBM but delivered no therapeutic light. The device operator was aware of assignment due to technical requirements. The researcher responsible for data collection and analysis was not masked. Participants and caregivers were informed of their group assignment only after the study was completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 17, 2025
• Study Start: March 30, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)