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

ConditionAMCI - Amnestic Mild Cognitive Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorUskudar University

About this trial

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:

1. Does t-PBM, when used together with cognitive training, improve memory and cognitive skills? 2. Does t-PBM change how certain brain areas communicate with each other, especially in the default mode network (DMN)?

Researchers will compare:

t-PBM plus cognitive training to sham (inactive) t-PBM plus the same cognitive training to see if the active light treatment leads to better cognitive improvement and healthier brain activity.

Participants will:

* 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 55 years or older

Diagnosis of amnestic Mild Cognitive Impairment (aMCI)

Disqualifiers

Presence of a neurological disorder

Presence of a severe psychiatric disorder

Having a pacemaker or other implanted medical device that is not MRI-compatible

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intervention Arm: Active TreatmentExperimental treatment 2 interventions
Group B: Control Arm: Sham/PlaceboSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline and after completion of the 8-session intervention (approximately 4 weeks)
2

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).

Time frame
From baseline to post-intervention assessment following 8 sessions

Secondary outcomes

1

Genotype-Based Comparison of Treatment Outcomes

This outcome measure evaluates group-based comparisons of treatment-related changes in cognitive performance and brain functional connectivity across COMT and APOE genotype groups following transcranial photobiomodulation, as a single composite comparison outcome. Genetic profile (grouping variable): COMT Val158Met polymorphism and APOE genotype (ε2, ε3, ε4 alleles), determined by genotyping analysis from peripheral blood samples; unit: genotype category (COMT: Val/Val, Val/Met, Met/Met; APOE: ε2 carrier, ε3/ε3, ε4 carrier). Cognitive performance measure: Montreal Cognitive Assessment (MoCA) total score; measurement tool: standardized MoCA test; unit: change in total score from baseline (points; range 0-30). Brain connectivity measure: Default Mode Network (DMN) functional connectivity; measurement tool: resting-state fMRI-based functional connectivity analysis using Pearson correlation of BOLD time series; unit: change in connectivity strength from baseline.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uskudar University

Lead sponsor

Source ClinicalTrials.gov
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