Subjective Cognitive Decline (SCD)NCT07445945
Physiological Effect of Non-invasive Photobiomodulation on Cognition and Mood in Older Adults With Subjective Cognitive Impairment
A study testing Photobiomodulation in people with Subjective Cognitive Decline (SCD) and Subjective Cognitive Impairment, run by Baycrest at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Subjective Cognitive Decline (SCD), Subjective Cognitive Impairment
- What is being tested?
- Photobiomodulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Affirmative responses to two questions on a self-report questionnaire: "Do you feel your memory is becoming worse?" "If so, are you concerned?"
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Rotman Research Institute
Toronto, Ontario, M6A 2E1
Principal Investigator, 416-785-2500 ext. 2017, jean.chen@utoronto.ca
About this study
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.
Read the 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.
- Being tested
- Photobiomodulation, Sham (No Treatment)
- Keywords
- Photobiomodulation, Light Therapy, Electroencephalography, MRI, Neuromodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationOther
the application of red and near-infrared light
Sham (No Treatment)Other
Control intervention; no photobiomodulation
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Participants will have the devices positioned but not turned on Receives: Other: Sham (No Treatment) |
| tPBM (forehead PBM) | Active comparator | Participants will have the devices positioned but only the tPBM device turned on Receives: Other: Photobiomodulation |
| iPBM (intranasal PBM) | Active comparator | Participants will have the devices positioned but only the iPBM device turned on Receives: Other: Photobiomodulation |
| vPBM (vagus PBM) | Active comparator | Participants will have the devices positioned but only the vPBM device turned on Receives: Other: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Depression Scale (Short Form)
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.
Measured: 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
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.
Measured: The first assessment will take place before participants receive treatment, and another session no more than 2 weeks after their final treatment session.
Secondary outcomes (4)
EEG signal metrics and spatial-temporal pattern
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.
Measured: 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
Alpha diversity measures diversity within a single sample, beta diversity focuses on the differences between samples.
Measured: Two nasal swab samples collected; one before the administration of the first treatment session, and one after the last treatment session.
Resting-state fMRI
Acquired using a research-dedicated whole-body 3T MRI system (Prisma, Siemens Medical Solutions). We will compute resting-state global functional-connectivity density.
Measured: 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
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.
Measured: Two nasal swab samples collected; one before the administration of the first treatment session, and one after the last treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Subjective Cognitive Decline (SCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baycrest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Chen, Baycrest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445945
- Sponsor's protocol ID
- REB 25-12
- Status last verified
- Oct 2025
- First submitted
- 14 Jul 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zomorrodi R, Loheswaran G, Pushparaj A, Lim L. Pulsed Near Infrared Transcranial and Intranasal Photobiomodulation Significantly Modulates Neural Oscillations: a pilot exploratory study. Sci Rep. 2019 Apr 19;9(1):6309. doi: 10.1038/s41598-019-42693-x.
PubMed 31004126Zollinger I, Bauer A, Blotenberg I, Brettschneider C, Buchholz M, Czock D, Dohring J, Escales C, Fankhaenel T, Frese T, Hoffmann W, Kaduszkiewicz H, Konig HH, Luppa M, Oey A, Pabst A, Sanftenberg L, Thyrian JR, Weiss J, Wendel F, Wiese B, Riedel-Heller SG, Gensichen J. Associations of Depressive Symptoms with Subjective Cognitive Decline in Elderly People-A Cross-Sectional Analysis from the AgeWell.de-Study. J Clin Med. 2023 Aug 10;12(16):5205. doi: 10.3390/jcm12165205.
PubMed 37629244Wang X, Tian F, Reddy DD, Nalawade SS, Barrett DW, Gonzalez-Lima F, Liu H. Up-regulation of cerebral cytochrome-c-oxidase and hemodynamics by transcranial infrared laser stimulation: A broadband near-infrared spectroscopy study. J Cereb Blood Flow Metab. 2017 Dec;37(12):3789-3802. doi: 10.1177/0271678X17691783. Epub 2017 Feb 9.
PubMed 28178891Van Lankveld, H., Chen, J.X., Zhong, X.Z., Chen, J.J., 2025. Consistent and real-time BOLD fMRI response to pulsed transcranial and intranasal photobiomodulation. , in: OHBM 2025 Annual Meeting. Presented at the OHBM 2025 Annual meeting.
Thompson SL, O'Leary GH, Austelle CW, Gruber E, Kahn AT, Manett AJ, Short B, Badran BW. A Review of Parameter Settings for Invasive and Non-invasive Vagus Nerve Stimulation (VNS) Applied in Neurological and Psychiatric Disorders. Front Neurosci. 2021 Jul 13;15:709436. doi: 10.3389/fnins.2021.709436. eCollection 2021.
PubMed 34326720Schiffer F, Johnston AL, Ravichandran C, Polcari A, Teicher MH, Webb RH, Hamblin MR. Psychological benefits 2 and 4 weeks after a single treatment with near infrared light to the forehead: a pilot study of 10 patients with major depression and anxiety. Behav Brain Funct. 2009 Dec 8;5:46. doi: 10.1186/1744-9081-5-46.
PubMed 19995444Saltmarche AE, Naeser MA, Ho KF, Hamblin MR, Lim L. Significant Improvement in Cognition in Mild to Moderately Severe Dementia Cases Treated with Transcranial Plus Intranasal Photobiomodulation: Case Series Report. Photomed Laser Surg. 2017 Aug;35(8):432-441. doi: 10.1089/pho.2016.4227. Epub 2017 Feb 10.
PubMed 28186867Salehpour F, Majdi A, Pazhuhi M, Ghasemi F, Khademi M, Pashazadeh F, Hamblin MR, Cassano P. Transcranial Photobiomodulation Improves Cognitive Performance in Young Healthy Adults: A Systematic Review and Meta-Analysis. Photobiomodul Photomed Laser Surg. 2019 Oct;37(10):635-643. doi: 10.1089/photob.2019.4673. Epub 2019 Sep 24.
PubMed 31549906Salehpour F, Khademi M, Hamblin MR. Photobiomodulation Therapy for Dementia: A Systematic Review of Pre-Clinical and Clinical Studies. J Alzheimers Dis. 2021;83(4):1431-1452. doi: 10.3233/JAD-210029.
PubMed 33935090Salehpour F, Gholipour-Khalili S, Farajdokht F, Kamari F, Walski T, Hamblin MR, DiDuro JO, Cassano P. Therapeutic potential of intranasal photobiomodulation therapy for neurological and neuropsychiatric disorders: a narrative review. Rev Neurosci. 2020 Apr 28;31(3):269-286. doi: 10.1515/revneuro-2019-0063.
PubMed 31812948Rashidi-Ranjbar, N., Churchill, N.W., Graham, S.J., Schneider, R., Rajji, T.K., Andreazza, A.C., Lim, L., Coull, J., Munoz, D.G., Fornazzari, L.R., Tom A. Schweizer, Fischer, C.E., 2024. A pilot study evaluating the feasibility, safety, and efficacy of transcranial photobiomodulation (tPBM) for the treatment of mild cognitive impairment (MCI): preliminary findings. Alzheimers. Dement. 20. https://doi.org/10.1002/alz.095049
Peruzzotti-Jametti L, Donega M, Giusto E, Mallucci G, Marchetti B, Pluchino S. The role of the immune system in central nervous system plasticity after acute injury. Neuroscience. 2014 Dec 26;283:210-221. doi: 10.1016/j.neuroscience.2014.04.036. Epub 2014 Apr 29.
PubMed 24785677Nawashiro H, Wada K, Nakai K, Sato S. Focal increase in cerebral blood flow after treatment with near-infrared light to the forehead in a patient in a persistent vegetative state. Photomed Laser Surg. 2012 Apr;30(4):231-3. doi: 10.1089/pho.2011.3044. Epub 2011 Nov 2.
PubMed 22047598Nairuz T, Sangwoo-Cho, Lee JH. Photobiomodulation Therapy on Brain: Pioneering an Innovative Approach to Revolutionize Cognitive Dynamics. Cells. 2024 Jun 3;13(11):966. doi: 10.3390/cells13110966.
PubMed 38891098Mou YK, Song XY, Wang HR, Wang Y, Liu WC, Yang T, Zhang MJ, Hu Y, Ren C, Song XC. Understanding the nose-brain axis and its role in related diseases: A conceptual review. Neurobiol Dis. 2024 Nov;202:106690. doi: 10.1016/j.nbd.2024.106690. Epub 2024 Oct 9.
PubMed 39389156
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effect of Non-invasive Photobiomodulation on Cognition and Mood in Older Adults With Subjective Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07445945
- Acronym / sponsor ID
- REB 25-12
- Keywords
- Photobiomodulation, Light Therapy, Electroencephalography, MRI, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- BaycrestUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Other: Sham (No Treatment)Participants will have the devices positioned but not turned on |
| tPBM (forehead PBM) | Active comparator | Other: PhotobiomodulationParticipants will have the devices positioned but only the tPBM device turned on |
| iPBM (intranasal PBM) | Active comparator | Other: PhotobiomodulationParticipants will have the devices positioned but only the iPBM device turned on |
| vPBM (vagus PBM) | Active comparator | Other: PhotobiomodulationParticipants will have the devices positioned but only the vPBM device turned on |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Affirmative responses to two questions on a self-report questionnaire: "Do you feel your memory is becoming worse?" "If so, are you concerned?"
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulationthe application of red and near-infrared light | Other | iPBM (intranasal PBM), tPBM (forehead PBM), vPBM (vagus PBM) |
| Sham (No Treatment)Control intervention; no photobiomodulation | Other | Sham |
Primary outcome
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.
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.
4 secondary outcomes
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
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 31004126Zomorrodi R, Loheswaran G, Pushparaj A, Lim L. Pulsed Near Infrared Transcranial and Intranasal Photobiomodulation Significantly Modulates Neural Oscillations: a pilot exploratory study. Sci Rep. 2019 Apr 19;9(1):6309. doi: 10.1038/s41598-019-42693-x.
- Background: PubMed 37629244Zollinger I, Bauer A, Blotenberg I, Brettschneider C, Buchholz M, Czock D, Dohring J, Escales C, Fankhaenel T, Frese T, Hoffmann W, Kaduszkiewicz H, Konig HH, Luppa M, Oey A, Pabst A, Sanftenberg L, Thyrian JR, Weiss J, Wendel F, Wiese B, Riedel-Heller SG, Gensichen J. Associations of Depressive Symptoms with Subjective Cognitive Decline in Elderly People-A Cross-Sectional Analysis from the AgeWell.de-Study. J Clin Med. 2023 Aug 10;12(16):5205. doi: 10.3390/jcm12165205.
- Background: PubMed 28178891Wang X, Tian F, Reddy DD, Nalawade SS, Barrett DW, Gonzalez-Lima F, Liu H. Up-regulation of cerebral cytochrome-c-oxidase and hemodynamics by transcranial infrared laser stimulation: A broadband near-infrared spectroscopy study. J Cereb Blood Flow Metab. 2017 Dec;37(12):3789-3802. doi: 10.1177/0271678X17691783. Epub 2017 Feb 9.
- BackgroundVan Lankveld, H., Chen, J.X., Zhong, X.Z., Chen, J.J., 2025. Consistent and real-time BOLD fMRI response to pulsed transcranial and intranasal photobiomodulation. , in: OHBM 2025 Annual Meeting. Presented at the OHBM 2025 Annual meeting.
- Background: PubMed 34326720Thompson SL, O'Leary GH, Austelle CW, Gruber E, Kahn AT, Manett AJ, Short B, Badran BW. A Review of Parameter Settings for Invasive and Non-invasive Vagus Nerve Stimulation (VNS) Applied in Neurological and Psychiatric Disorders. Front Neurosci. 2021 Jul 13;15:709436. doi: 10.3389/fnins.2021.709436. eCollection 2021.
- Background: PubMed 19995444Schiffer F, Johnston AL, Ravichandran C, Polcari A, Teicher MH, Webb RH, Hamblin MR. Psychological benefits 2 and 4 weeks after a single treatment with near infrared light to the forehead: a pilot study of 10 patients with major depression and anxiety. Behav Brain Funct. 2009 Dec 8;5:46. doi: 10.1186/1744-9081-5-46.
- Background: PubMed 28186867Saltmarche AE, Naeser MA, Ho KF, Hamblin MR, Lim L. Significant Improvement in Cognition in Mild to Moderately Severe Dementia Cases Treated with Transcranial Plus Intranasal Photobiomodulation: Case Series Report. Photomed Laser Surg. 2017 Aug;35(8):432-441. doi: 10.1089/pho.2016.4227. Epub 2017 Feb 10.
- Background: PubMed 31549906Salehpour F, Majdi A, Pazhuhi M, Ghasemi F, Khademi M, Pashazadeh F, Hamblin MR, Cassano P. Transcranial Photobiomodulation Improves Cognitive Performance in Young Healthy Adults: A Systematic Review and Meta-Analysis. Photobiomodul Photomed Laser Surg. 2019 Oct;37(10):635-643. doi: 10.1089/photob.2019.4673. Epub 2019 Sep 24.
- Background: PubMed 33935090Salehpour F, Khademi M, Hamblin MR. Photobiomodulation Therapy for Dementia: A Systematic Review of Pre-Clinical and Clinical Studies. J Alzheimers Dis. 2021;83(4):1431-1452. doi: 10.3233/JAD-210029.
- Background: PubMed 31812948Salehpour F, Gholipour-Khalili S, Farajdokht F, Kamari F, Walski T, Hamblin MR, DiDuro JO, Cassano P. Therapeutic potential of intranasal photobiomodulation therapy for neurological and neuropsychiatric disorders: a narrative review. Rev Neurosci. 2020 Apr 28;31(3):269-286. doi: 10.1515/revneuro-2019-0063.
- BackgroundRashidi-Ranjbar, N., Churchill, N.W., Graham, S.J., Schneider, R., Rajji, T.K., Andreazza, A.C., Lim, L., Coull, J., Munoz, D.G., Fornazzari, L.R., Tom A. Schweizer, Fischer, C.E., 2024. A pilot study evaluating the feasibility, safety, and efficacy of transcranial photobiomodulation (tPBM) for the treatment of mild cognitive impairment (MCI): preliminary findings. Alzheimers. Dement. 20. https://doi.org/10.1002/alz.095049
- Background: PubMed 24785677Peruzzotti-Jametti L, Donega M, Giusto E, Mallucci G, Marchetti B, Pluchino S. The role of the immune system in central nervous system plasticity after acute injury. Neuroscience. 2014 Dec 26;283:210-221. doi: 10.1016/j.neuroscience.2014.04.036. Epub 2014 Apr 29.
- Individual participant dataSharing planned: No
Related trials for Subjective Cognitive Decline (SCD)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
The Efficacy of an IADL-based Non-immersive Virtual Reality Training Program to Enhance ADL Performance and Cognitive Function for Persons at Risk of Dementia
Cognitive Enhancement, Subjective Cognitive Decline (SCD)
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
Recruiting
Chinese Classics Recitation Training in Subjective Cognitive Decline
Subjective Cognitive Decline (SCD), Subjective Cognitive Decline
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Subjective Cognitive Decline (SCD) and Subjective Cognitive Impairment, run by Baycrest at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (416-785-2500 ext. 2017, jean.chen@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07445945, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.