Physiological Effect of Non-invasive Photobiomodulation on Cognition and Mood in Older Adults With Subjective Cognitive Impairment

February 25, 2026 updated by: Jean Chen, Baycrest

Subjective cognitive impairment (SCI) is a non-clinical condition manifesting as a self-reported decline in cognitive function without objective clinical evidence, and is prevalent among older adults and strongly associated with declining mood. This study explores the potential of photobiomodulation (PBM) as a therapeutic intervention for SCI. PBM, using near-infrared light, is a non-invasive neuromodulation approach that has shown promise in improving neuronal function, blood flow, and reducing inflammation in both healthy adults and patients with neurological conditions, including dementia and depression. This study proposes investigating the potential of forehead (tPBM), intranasal (iPBM) and vagal (vPBM) PBM to enhance mood and cognitive function in individuals with SCI as a proof of concept for the future use of PBM as therapy for cognitive decline in general.

This study will recruit approximately 80 participants with SCI for the study, and the total expected duration of the participant's participation in the study is 5 weeks. The active and sham Neuro 5T device consisting of a headset with a built-in controller, nasal and neck applicators will be used. The nasal and neck applicators each contains a single LED and will be placed into the nostril or neck and secured into place. The headset contains multiple LEDs in a wearable applicator and may be adjusted. The Neuro 5T also contains telemetry features to allow documentation of patient usage of the device. LEDs are semiconductor electronic components that emit light. Participants will be given PBM devices for in-home usage, 2 times a day, 7 days a week, for 5 weeks. Participants will undergo EEG, MRI, cognitive and nasal microbiome assessments before and after the 5-week period.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will recruit approximately 80 participants with SCI for the study, and the total expected duration of the participant's participation in the study is 5 weeks. The active and sham Neuro 5T device consisting of a headset with a built-in controller, nasal and neck applicators will be used. The nasal and neck applicators each contains a single LED and will be placed into the nostril or neck and secured into place. The headset contains multiple LEDs in a wearable applicator and may be adjusted. The Neuro 5T also contains telemetry features to allow documentation of patient usage of the device. LEDs are semiconductor electronic components that emit light. Participants will be given PBM devices for in-home usage, 2 times a day, 7 days a week, for 5 weeks. Participants will undergo EEG, MRI, cognitive and nasal microbiome assessments before and after the 5-week period.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6A 2E1
        • Rotman Research Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Affirmative responses to two questions on a self-report questionnaire: "Do you feel your memory is becoming worse?" "If so, are you concerned?"

Exclusion Criteria:

  • Presence of clinically diagnosed dementia, mild cognitive impairment, depression, post-traumatic stress disorder, obsessive-compulsive disorder, eating disorder(s), schizophrenia, or other psychiatric disorders.
  • History of a manic, hypomanic, or mixed depressive episode.
  • Treatment with electroconvulsive therapy, intravenous and/or intranasal ketamine in the 6-weeks prior to study enrolment.
  • History of substance-use disorder in the past 12 months.
  • Presence of current alcohol-use disorder.
  • A positive urine toxicology screen for non-prescribed substance use.
  • A positive pregnancy test at screening.
  • A history of major medical or neurological illness.
  • A history of traumatic brain injury, stroke, seizures, or previous brain surgery.
  • Current use of anti-coagulants.
  • Contraindications to magnetic resonance imaging (MRI) scanning.
  • Being currently involved in other intervention studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham
Participants will have the devices positioned but not turned on
Other: Sham (No Treatment)
Control intervention; no photobiomodulation
Active Comparator: tPBM (forehead PBM)
Participants will have the devices positioned but only the tPBM device turned on
Other: Photobiomodulation
the application of red and near-infrared light
Active Comparator: iPBM (intranasal PBM)
Participants will have the devices positioned but only the iPBM device turned on
Other: Photobiomodulation
the application of red and near-infrared light
Active Comparator: vPBM (vagus PBM)
Participants will have the devices positioned but only the vPBM device turned on
Other: Photobiomodulation
the application of red and near-infrared light

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geriatric Depression Scale (Short Form)
Time Frame: The first assessment will take place before participants receive treatment, and another session no more than 2 weeks after their final treatment session.
The Geriatric Depression Scale (Short Form), or GDS-SF, is a 15-item questionnaire used to screen older adults for depression. It is a simplified version of the original 30-item GDS, designed to be easier to administer, especially to those who are physically ill, easily fatigued, have short attention spans, or have mild cognitive impairment. A score of 5 or greater suggests the need for further evaluation for depression.
The first assessment will take place before participants receive treatment, and another session no more than 2 weeks after their final treatment session.
Montreal Cognitive Assessment
Time Frame: The first assessment will take place before participants receive treatment, and another session no more than 2 weeks after their final treatment session.
The Montreal Cognitive Assessment (MoCA) is a rapid screening instrument designed to detect mild cognitive impairment. It assesses various cognitive domains, including attention, memory, language, and executive functions. The MoCA is a brief test, taking approximately 10 minutes to administer, and is widely used in clinical and research settings.
The first assessment will take place before participants receive treatment, and another session no more than 2 weeks after their final treatment session.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG signal metrics and spatial-temporal pattern
Time Frame: Two sessions, to be completed no more than 2 weeks before the start of the treatment sessions and then no more than 2 weeks after the conclusion of all treatment sessions
The electroenphalography (EEG) recordings will be conducted at Baycrest on a 256 channel EGI-Magstim system. We will position an electrode net over the subject's head and face with small sponges soaked in a saline solution. We will also place two single electrodes on the chest. We will assess the power and entropy of alpha, low-frequency (delta and theta) and high (beta and gamma) EEG bands in the resting state.
Two sessions, to be completed no more than 2 weeks before the start of the treatment sessions and then no more than 2 weeks after the conclusion of all treatment sessions
Alpha diversity
Time Frame: Two nasal swab samples collected; one before the administration of the first treatment session, and one after the last treatment session.
Alpha diversity measures diversity within a single sample, beta diversity focuses on the differences between samples.
Two nasal swab samples collected; one before the administration of the first treatment session, and one after the last treatment session.
Resting-state fMRI
Time Frame: Two scans, to be completed no more than 2 weeks before the start of the first treatment session and no more than 2 weeks after the conclusion of the last treatment session.
Acquired using a research-dedicated whole-body 3T MRI system (Prisma, Siemens Medical Solutions). We will compute resting-state global functional-connectivity density.
Two scans, to be completed no more than 2 weeks before the start of the first treatment session and no more than 2 weeks after the conclusion of the last treatment session.
Beta diversity
Time Frame: Two nasal swab samples collected; one before the administration of the first treatment session, and one after the last treatment session.
Beta diversity in the microbiome refers to the dissimilarity or differences in microbial community composition between two or more samples. It essentially quantifies how much the microbial communities vary across different environments, sites, or conditions.
Two nasal swab samples collected; one before the administration of the first treatment session, and one after the last treatment session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baycrest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

July 14, 2025

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB 25-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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