Transcranial Photobiomodulation for Executive Function in Bipolar Disorder (TPEB): Study Protocol
Abstract
:1. Introduction
1.1. Bipolar Disorder
1.2. Transcranial Photobiomodulation (t-PBM)
1.3. Preliminary Data
1.3.1. Within Our Institution
1.3.2. Within Our Collaborators in the Region
1.3.3. Within Our International Collaborators
1.4. Innovation
2. Aims
3. Gambling Tasks
3.1. Iowa Gambling Task
3.2. Reward Gambling Task
4. Study Design, Schedule, and Assessments
4.1. Stimulation Sessions
4.2. Outcomes
5. Subjects
6. Transcranial Photobiomodulation Administration
7. MRI Scanning and Imagining Processing
8. Statistical Analysis
9. Demographic Data on Existing Participants
10. Discussion
11. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Measure | Pre-Screen | Screen | Baseline | Tx 1 | Tx 2 | Tx 3 | Tx 4 | Tx 5 | Check-In | Follow-Up |
---|---|---|---|---|---|---|---|---|---|---|
Pre-Screen Form | X | |||||||||
ASRM | X | X | ||||||||
PHQ-9 | X | X | ||||||||
Consent Form | X | |||||||||
Demographic Form | X | |||||||||
Concomitant Treatments Log | X | X | X | X | X | X | X | X | X | |
AE | X | X | X | X | X | X | X | X | ||
Prior Treatment Log | X | |||||||||
Medical History | X | |||||||||
Drug Screen | X | |||||||||
Pregnancy Test | X | |||||||||
MINI | X | |||||||||
C-SSRS | X | X | X | X | ||||||
MOODS-SR Lifetime | X | |||||||||
YMRS | X | |||||||||
Screening Note | X | |||||||||
NIS-SCS | X | |||||||||
MOODS-SR Last Week | X | X | X | |||||||
BIS | X | X | X | X | ||||||
I-7 | X | X | X | |||||||
BRIEF | X | X | X | |||||||
t-PBM | X * | X | X | X | X * | |||||
Reward Gambling Task | X | X * | X * | X | ||||||
lowa Gambling Task | X | X | X | X | ||||||
Vitals | X | X | ||||||||
MRI Safety Form | X | X | X | |||||||
SAFTEE | X | X | X | |||||||
CGI-S | X | X | X | |||||||
CGI-I | X | X | ||||||||
PBQ | X | |||||||||
TSRQ | X | X | X | X | X | |||||
CAST-IRR | X | X | X | X | X | X | ||||
Intervention Tracking | X | X | X | X | X | |||||
Adverse Event Log | X | X | X | X | X | X | X | X |
Measure (Unit) | Value |
---|---|
Wavelength (nm) | 808 |
Exposure time (s) | 333 |
Area of exposure (cm2) | 24 |
Irradiance, Power Density (mW/cm2) | 300 |
Fluence (J/cm2) | 100 |
Total Energy (kJ) | 2.4 |
NIR Source | Laser |
Laser Output (W) | 3.5 per fiber (7 total) |
Wave Mode | Continuous |
Anatomical Targets | F4 & Fp2 |
Device | Litecure’s LightForce® EXPi Deep Tissue Laser Therapy TM System, Transcranial PhotoBioModulation-1000 (t-PBM-2.0) |
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© 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
Share and Cite
Coelho, D.R.A.; Puerto, A.M.H.; Vieira, W.F.; Lohmann, C.A.; Shahab, M.H.; Gersten, M.B.; Vahedifard, F.; McEachern, K.M.; Clancy, J.A.; Cassano, P. Transcranial Photobiomodulation for Executive Function in Bipolar Disorder (TPEB): Study Protocol. Photonics 2024, 11, 761. https://doi.org/10.3390/photonics11080761
Coelho DRA, Puerto AMH, Vieira WF, Lohmann CA, Shahab MH, Gersten MB, Vahedifard F, McEachern KM, Clancy JA, Cassano P. Transcranial Photobiomodulation for Executive Function in Bipolar Disorder (TPEB): Study Protocol. Photonics. 2024; 11(8):761. https://doi.org/10.3390/photonics11080761
Chicago/Turabian StyleCoelho, David Richer Araujo, Aura Maria Hurtado Puerto, Willians Fernando Vieira, Carlos Alberto Lohmann, Muhammad Hamza Shahab, Maia Beth Gersten, Farzan Vahedifard, Kayla Marie McEachern, Julie A. Clancy, and Paolo Cassano. 2024. "Transcranial Photobiomodulation for Executive Function in Bipolar Disorder (TPEB): Study Protocol" Photonics 11, no. 8: 761. https://doi.org/10.3390/photonics11080761