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The purpose of this study is to see if a special light treatment, called photobiomodulation, can help people with memory problems such as Mild Cognitive Impairment or Mild Dementia due to Alzheimer's disease. The light is given to the forehead using an FDA-cleared medical device. This device is cleared to provide topical heating to elevate tissue temperature for temporary relief of muscle and joint pain, muscle spasm and stiffness associated with arthritis. It also increases blood circulation and relaxes muscle tissue. This device is being used "off-label," meaning it will be used in a way that is different than its cleared use.
We want to learn whether this light treatment can improve executive function, and whether it changes certain inflammatory and neurodegeneration related signals in the blood. To do this, we will apply the photobiomodulation device to your forehead. We will also ask you questions and give you cognitive tests before and after light treatment. We will also collect blood samples before and after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active photobiomodulation | Experimental | 1064nm photobiomodulation to be applied for 8 minutes total each session |
|
| Sham | Sham Comparator | only 5 seconds of photobiomodulation, to account for small amount of participants who reported an initial warm sensation upon stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photobiomodulation | Device | 1064nm transcranial photobiomodulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| NIH Toolbox | Three validated NIH Toolbox tasks:
| Baseline measurements will be performed prior to intervention, post-treatment (week 5), and lastly at the 3-month follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Glial Fibrillary Acidic Protein (GFAP) | Plasma GFAP concentration (pg/ml) measure using the S-PLEX Assay | Will be performed at baseline and at 3 month follow up |
| Neurofilament Light Chain (NfL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enrique Vargas Vargas, MD | Contact | 972-281-7187 | enrique.vargas@cshs.org | |
| Golnaz Yadollahikhales, MD | Contact | 310-385-6016 | Golnaz.Yadollahikhales@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Golnaz Yadollahikhales, MD | Cedars Siinai Medical Center Department of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CSMC | Recruiting | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35847661 | Background | Zhu G, Tong Q, Ye X, Li J, Zhou L, Sun P, Liang F, Zhong S, Cheng R, Zhang J. Phototherapy for Cognitive Function in Patients With Dementia: A Systematic Review and Meta-Analysis. Front Aging Neurosci. 2022 Jun 30;14:936489. doi: 10.3389/fnagi.2022.936489. eCollection 2022. | |
| 36967820 | Background | Luo G, Zhang J, Song Z, Wang Y, Wang X, Qu H, Wang F, Liu C, Gao F. Effectiveness of non-pharmacological therapies on cognitive function in patients with dementia-A network meta-analysis of randomized controlled trials. Front Aging Neurosci. 2023 Mar 2;15:1131744. doi: 10.3389/fnagi.2023.1131744. eCollection 2023. |
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All IPD that underlie results in a publication
Starting 6 months after publication all IPD and supporting information will be made available
All information regarding participants' data on primary and secondary outcome measures that will be used in publication
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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Plasma Neurofilament Light Chain (NfL) concentration (pg/ml) measure using the S-PLEX Assay
| Baseline and 3-month follow up |
| Total Tau | Plasma total tau concentration (pg/ml) measure using the S-PLEX Assay | Baseline and 3-month follow up |
| Interferon-γ (IFN-γ) | Plasma GFAP concentration (pg/ml) measure using the V-PLEX Assay | Baseline and 3-month follow up |
| Interleukin-1β (IL-1β) | Plasma IL-1β concentration measured using the V-PLEX assay | Baseline and 3-month follow up |
| Tumor Necrosis Factor-α (TNF-α) | Plasma TNF-α concentration (pg/ml) measured using the V-PLEX assay | Baseline and 3-month follow up |
| 30474306 | Background | Chan AS, Lee TL, Yeung MK, Hamblin MR. Photobiomodulation improves the frontal cognitive function of older adults. Int J Geriatr Psychiatry. 2019 Feb;34(2):369-377. doi: 10.1002/gps.5039. Epub 2018 Dec 10. |
| 37298224 | Background | Su M, Nizamutdinov D, Liu H, Huang JH. Recent Mechanisms of Neurodegeneration and Photobiomodulation in the Context of Alzheimer's Disease. Int J Mol Sci. 2023 May 25;24(11):9272. doi: 10.3390/ijms24119272. |
| Background | Gonzalez-Lima, F. (2021). Neuroprotection and Neurocognitive Augmentation by Photobiomodulation. In: Opris, I., A. Lebedev, M., F. Casanova, M. (eds) Modern Approaches to Augmentation of Brain Function. Contemporary Clinical Neuroscience. Springer, Cham. https://doi.org/10.1007/978-3-030-54564-2_9 |
| 28466195 | Background | Vargas E, Barrett DW, Saucedo CL, Huang LD, Abraham JA, Tanaka H, Haley AP, Gonzalez-Lima F. Beneficial neurocognitive effects of transcranial laser in older adults. Lasers Med Sci. 2017 Jul;32(5):1153-1162. doi: 10.1007/s10103-017-2221-y. Epub 2017 May 2. |
| 37972955 | Background | Boyer D, Hu A, Warrow D, Xavier S, Gonzalez V, Lad E, Rosen RB, Do D, Schneiderman T, Ho A, Munk MR, Jaffe G, Tedford SE, Croissant CL, Walker M, Ruckert R, Tedford CE. LIGHTSITE III: 13-Month Efficacy and Safety Evaluation of Multiwavelength Photobiomodulation in Nonexudative (Dry) Age-Related Macular Degeneration Using the Lumithera Valeda Light Delivery System. Retina. 2024 Mar 1;44(3):487-497. doi: 10.1097/IAE.0000000000003980. |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |