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

NCT07445945 — Not applicable, Not yet recruiting, 80 participants, Baycrest
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RegistryNCT07445945
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment80 (Estimated)
SponsorBaycrest (Other)
ConditionsSubjective Cognitive Decline (SCD), Subjective Cognitive Impairment
InterventionsPhotobiomodulation, Sham (No Treatment) (Other)
Datesstart 2026-06-01 (estimated), primary completion 2028-07-01 (estimated), completion 2028-07-01 (estimated), first posted 2026-03-03, last updated 2026-03-03
Locations1 site in Canada

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-Summary

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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
ShamSham comparatorOther: Sham (No Treatment)Participants will have the devices positioned but not turned on
tPBM (forehead PBM)Active comparatorOther: PhotobiomodulationParticipants will have the devices positioned but only the tPBM device turned on
iPBM (intranasal PBM)Active comparatorOther: PhotobiomodulationParticipants will have the devices positioned but only the iPBM device turned on
vPBM (vagus PBM)Active comparatorOther: PhotobiomodulationParticipants will have the devices positioned but only the vPBM device turned on
  • Photobiomodulation (Other): the application of red and near-infrared light
  • Sham (No Treatment) (Other): Control intervention; no photobiomodulation

+Outcome measures

Primary outcomes

  • Geriatric Depression Scale (Short Form) [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.
  • Montreal Cognitive Assessment [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.

Secondary outcomes

  • EEG signal metrics and spatial-temporal pattern [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.
  • Alpha diversity [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.
  • Resting-state fMRI [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.
  • Beta diversity [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.

+Eligibility

Sex: All, ages: 50 Years to 75 Years

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.

+Locations (1)

FacilityCityCountryStatus
Rotman Research InstituteToronto, OntarioCanada

+Publications

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