Reported Side Effects, Weight and Blood Pressure, after Repeated Sessions of Transcranial Photobiomodulation

Paolo Cassano; Marco Antonio Caldieraro; Richard Norton; David Mischoulon; Nhi Ha Trinh; Maren Nyer; Christina Dording; Michael R. Hamblin; Benjamin Campbell; Dan V. Iosifescu

doi:10.1089/photob.2019.4678

Reported Side Effects, Weight and Blood Pressure, after Repeated Sessions of Transcranial Photobiomodulation

Paolo Cassano, Marco Antonio Caldieraro, Richard Norton, David Mischoulon, Nhi Ha Trinh, Maren Nyer, Christina Dording, Michael R. Hamblin, Benjamin Campbell, Dan V. Iosifescu

Research output: Contribution to journal › Article › peer-review

32 Citations (Scopus)

Abstract

Background: Transcranial photobiomodulation (t-PBM) consists in the delivery of near-infrared light (NIR) to the scalp, directed to cortical areas of the brain. NIR t-PBM recently emerged as a potential therapy for depression, although safety of repeated treatments has not been adequately explored. Objective: This study assessed incidence of side effects, including weight and blood pressure changes, during repeated sessions of NIR t-PBM using a light-emitting diode source. Methods: We performed a secondary analysis of a double-blind clinical trial on t-PBM for major depressive disorder. Eighteen individuals received NIR t-PBM (n = 9) or sham (n = 9) twice weekly for 8 weeks. Side effects were assessed using the Systematic Assessment for Treatment-Emergent Effects-Specific Inquiry. In 14 individuals (n_NIR = 6 vs. n_sham = 8), body weight and systemic blood pressure were recorded at baseline and end-point. Results: More subjects in the NIR t-PBM group experienced side effects compared to sham, but only a trend for statistical significance was observed (χ² = 3.60; df = 1; p = 0.058). The rate of side effects described by participants as "severe" in intensity was low and similar between the treatment groups (χ² = 0.4; df = 1; p = 0.53), with no serious adverse events. Most side effects resolved during the study and treatment interruption were not required. Changes in weight and systolic blood pressure across groups were neither significant nor approached significance. In the NIR t-PBM group, diastolic blood pressure increased and reached statistical - however not clinical - significance (5.67 ± 7.26 vs. -6.13 ± 6.88; z = -2.40, p = 0.016). Conclusions: This small-sample, exploratory study indicates repeated sessions of NIR t-PBM might be associated with treatment-emergent side effects. The systemic metabolic and hemodynamic profile of repeated t-PBM appeared benign. Future studies with larger samples and longer follow-up are needed to more accurately determine the side-effect profile and safety of NIR t-PBM.

Original language	English
Pages (from-to)	651-656
Number of pages	6
Journal	Photobiomodulation, Photomedicine, and Laser Surgery
Volume	37
Issue number	10
DOIs	https://doi.org/10.1089/photob.2019.4678
Publication status	Published - Oct 2019
Externally published	Yes

Keywords

LLLT
NIR
depression
low-level light therapy
near infrared
photobiomodulation
randomized controlled trial
side effects

ASJC Scopus subject areas

Biomedical Engineering
Radiology, Nuclear Medicine and Imaging

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10.1089/photob.2019.4678

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Cassano, P., Caldieraro, M. A., Norton, R., Mischoulon, D., Trinh, N. H., Nyer, M., Dording, C., Hamblin, M. R., Campbell, B., & Iosifescu, D. V. (2019). Reported Side Effects, Weight and Blood Pressure, after Repeated Sessions of Transcranial Photobiomodulation. Photobiomodulation, Photomedicine, and Laser Surgery, 37(10), 651-656. https://doi.org/10.1089/photob.2019.4678

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title = "Reported Side Effects, Weight and Blood Pressure, after Repeated Sessions of Transcranial Photobiomodulation",

abstract = "Background: Transcranial photobiomodulation (t-PBM) consists in the delivery of near-infrared light (NIR) to the scalp, directed to cortical areas of the brain. NIR t-PBM recently emerged as a potential therapy for depression, although safety of repeated treatments has not been adequately explored. Objective: This study assessed incidence of side effects, including weight and blood pressure changes, during repeated sessions of NIR t-PBM using a light-emitting diode source. Methods: We performed a secondary analysis of a double-blind clinical trial on t-PBM for major depressive disorder. Eighteen individuals received NIR t-PBM (n = 9) or sham (n = 9) twice weekly for 8 weeks. Side effects were assessed using the Systematic Assessment for Treatment-Emergent Effects-Specific Inquiry. In 14 individuals (nNIR = 6 vs. nsham = 8), body weight and systemic blood pressure were recorded at baseline and end-point. Results: More subjects in the NIR t-PBM group experienced side effects compared to sham, but only a trend for statistical significance was observed (χ2 = 3.60; df = 1; p = 0.058). The rate of side effects described by participants as {"}severe{"} in intensity was low and similar between the treatment groups (χ2 = 0.4; df = 1; p = 0.53), with no serious adverse events. Most side effects resolved during the study and treatment interruption were not required. Changes in weight and systolic blood pressure across groups were neither significant nor approached significance. In the NIR t-PBM group, diastolic blood pressure increased and reached statistical - however not clinical - significance (5.67 ± 7.26 vs. -6.13 ± 6.88; z = -2.40, p = 0.016). Conclusions: This small-sample, exploratory study indicates repeated sessions of NIR t-PBM might be associated with treatment-emergent side effects. The systemic metabolic and hemodynamic profile of repeated t-PBM appeared benign. Future studies with larger samples and longer follow-up are needed to more accurately determine the side-effect profile and safety of NIR t-PBM.",

keywords = "LLLT, NIR, depression, low-level light therapy, near infrared, photobiomodulation, randomized controlled trial, side effects",

author = "Paolo Cassano and Caldieraro, {Marco Antonio} and Richard Norton and David Mischoulon and Trinh, {Nhi Ha} and Maren Nyer and Christina Dording and Hamblin, {Michael R.} and Benjamin Campbell and Iosifescu, {Dan V.}",

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year = "2019",

month = oct,

doi = "10.1089/photob.2019.4678",

language = "English",

volume = "37",

pages = "651--656",

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T1 - Reported Side Effects, Weight and Blood Pressure, after Repeated Sessions of Transcranial Photobiomodulation

AU - Cassano, Paolo

AU - Caldieraro, Marco Antonio

AU - Norton, Richard

AU - Mischoulon, David

AU - Trinh, Nhi Ha

AU - Nyer, Maren

AU - Dording, Christina

AU - Hamblin, Michael R.

AU - Campbell, Benjamin

AU - Iosifescu, Dan V.

PY - 2019/10

Y1 - 2019/10

N2 - Background: Transcranial photobiomodulation (t-PBM) consists in the delivery of near-infrared light (NIR) to the scalp, directed to cortical areas of the brain. NIR t-PBM recently emerged as a potential therapy for depression, although safety of repeated treatments has not been adequately explored. Objective: This study assessed incidence of side effects, including weight and blood pressure changes, during repeated sessions of NIR t-PBM using a light-emitting diode source. Methods: We performed a secondary analysis of a double-blind clinical trial on t-PBM for major depressive disorder. Eighteen individuals received NIR t-PBM (n = 9) or sham (n = 9) twice weekly for 8 weeks. Side effects were assessed using the Systematic Assessment for Treatment-Emergent Effects-Specific Inquiry. In 14 individuals (nNIR = 6 vs. nsham = 8), body weight and systemic blood pressure were recorded at baseline and end-point. Results: More subjects in the NIR t-PBM group experienced side effects compared to sham, but only a trend for statistical significance was observed (χ2 = 3.60; df = 1; p = 0.058). The rate of side effects described by participants as "severe" in intensity was low and similar between the treatment groups (χ2 = 0.4; df = 1; p = 0.53), with no serious adverse events. Most side effects resolved during the study and treatment interruption were not required. Changes in weight and systolic blood pressure across groups were neither significant nor approached significance. In the NIR t-PBM group, diastolic blood pressure increased and reached statistical - however not clinical - significance (5.67 ± 7.26 vs. -6.13 ± 6.88; z = -2.40, p = 0.016). Conclusions: This small-sample, exploratory study indicates repeated sessions of NIR t-PBM might be associated with treatment-emergent side effects. The systemic metabolic and hemodynamic profile of repeated t-PBM appeared benign. Future studies with larger samples and longer follow-up are needed to more accurately determine the side-effect profile and safety of NIR t-PBM.

AB - Background: Transcranial photobiomodulation (t-PBM) consists in the delivery of near-infrared light (NIR) to the scalp, directed to cortical areas of the brain. NIR t-PBM recently emerged as a potential therapy for depression, although safety of repeated treatments has not been adequately explored. Objective: This study assessed incidence of side effects, including weight and blood pressure changes, during repeated sessions of NIR t-PBM using a light-emitting diode source. Methods: We performed a secondary analysis of a double-blind clinical trial on t-PBM for major depressive disorder. Eighteen individuals received NIR t-PBM (n = 9) or sham (n = 9) twice weekly for 8 weeks. Side effects were assessed using the Systematic Assessment for Treatment-Emergent Effects-Specific Inquiry. In 14 individuals (nNIR = 6 vs. nsham = 8), body weight and systemic blood pressure were recorded at baseline and end-point. Results: More subjects in the NIR t-PBM group experienced side effects compared to sham, but only a trend for statistical significance was observed (χ2 = 3.60; df = 1; p = 0.058). The rate of side effects described by participants as "severe" in intensity was low and similar between the treatment groups (χ2 = 0.4; df = 1; p = 0.53), with no serious adverse events. Most side effects resolved during the study and treatment interruption were not required. Changes in weight and systolic blood pressure across groups were neither significant nor approached significance. In the NIR t-PBM group, diastolic blood pressure increased and reached statistical - however not clinical - significance (5.67 ± 7.26 vs. -6.13 ± 6.88; z = -2.40, p = 0.016). Conclusions: This small-sample, exploratory study indicates repeated sessions of NIR t-PBM might be associated with treatment-emergent side effects. The systemic metabolic and hemodynamic profile of repeated t-PBM appeared benign. Future studies with larger samples and longer follow-up are needed to more accurately determine the side-effect profile and safety of NIR t-PBM.

KW - LLLT

KW - NIR

KW - depression

KW - low-level light therapy

KW - near infrared

KW - photobiomodulation

KW - randomized controlled trial

KW - side effects

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DO - 10.1089/photob.2019.4678

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AN - SCOPUS:85074113690

SN - 2578-5478

VL - 37

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JO - Photobiomodulation, Photomedicine, and Laser Surgery

JF - Photobiomodulation, Photomedicine, and Laser Surgery

IS - 10

ER -

Reported Side Effects, Weight and Blood Pressure, after Repeated Sessions of Transcranial Photobiomodulation

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