Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression (TRIADE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04366258
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : November 5, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This study will compare the effect of three transcranial photobiomodulation (t-PBM) doses (high, middle, and low irradiance) to sham t-PBM on PFC CBF as assessed with fMRI (BOLD) in this multi-center, phase I, double-blinded, dose-ranging, controlled, crossover study of 30 subjects with MDD. All eligible participants will undergo four sessions of t-PBM during fMRI so that they experience irradiances of 50, 300 and 700 mW/cm2 as well as sham. The order of dose administration will be randomized and t-PBM will be administered with the LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Transcranial photobiomodulator Device: Sham Not Applicable

Detailed Description:
The purpose of this research study is to determine if application of near infrared energy to the forehead can change blood flow in the brains of people with depression. Near infrared energy is like light but is not visible to the human eye. This research study will compare near infrared exposure with a placebo or sham procedure. The sham procedure will look and feel just like the near infrared procedure but won't include near infrared exposure.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: four sessions of t-PBM during fMRI, each session will occur, in random order, with t-PBM irradiances of 50, 300 and 700 mW/cm2 as well as sham.
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: t-PBM at High, Middle, Low Irradiance, Sham
Participants first receive t-PBM at irradiance doses of 770 mW/cm2, then 300 mW/cm2, then 50 mW/cm2, and then 0 mW/cm2.
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at High, Middle Irradiance, Sham, Low Irradiance
Participants first receive t-PBM at irradiance doses of 770 mW/cm2, then 300 mW/cm2, then 0 mW/cm2, and then 50 mW/cm2.
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at High, Low, Middle Irradiance Sham
Participants first receive t-PBM at irradiance doses of 770 mW/cm2, then 50 mW/cm2, then 300 mW/cm2, and then 0 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at High, Low Irradiance, Sham, Middle Irradiance
Participants first receive t-PBM at irradiance doses of 770 mW/cm2, then 50 mW/cm2, then 0 mW/cm2 and then 300 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at High Irradiance, Sham, Middle, Low Irradiance
Participants first receive t-PBM at irradiance doses of 770 mW/cm2, then 0 mW/cm2, then 300 mW/cm2, and then 50 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at High Irradiance, Sham, Low, Middle Irradiance
Participants first receive t-PBM at irradiance doses of 770 mW/cm2, then 0 mW/cm2, then 50 mW/cm2, and then 300 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Middle, High, Low Irradiance, Sham
Participants first receive t-PBM at irradiance doses of 300 mW/cm2, then 770 mW/cm2, then 50 mW/cm2, and then 0 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Middle, High Irradiance, Sham, Low Irradiance
Participants first receive t-PBM at irradiance doses of 300 mW/cm2, then 770 mW/cm2, then 0 mW/cm2, and then 50 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Middle, Low, High Irradiance, Sham
Participants first receive t-PBM at irradiance doses of 300 mW/cm2, then 50 mW/cm2, then 770 mW/cm2, and then 0 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Middle, Low Irradiance, Sham, High Irradiance
Participants first receive t-PBM at irradiance doses of 300 mW/cm2, then 50 mW/cm2, then 0 mW/cm2, and then 770 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Middle Irradiance Sham High Irradiance Low Irradiance
Participants first receive t-PBM at irradiance doses of 300 mW/cm2, then 0 mW/cm2, then 770 mW/cm2, and then 50 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Middle Irradiance, Sham Low, High Irradiance
Participants first receive t-PBM at irradiance doses of 300 mW/cm2, then 0 mW/cm2, then 50 mW/cm2, and then 770 mW/cm2,
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Low High Middle Irradiance, Sham
Participants first receive t-PBM at irradiance doses of 50 mW/cm2, then 770 mW/cm2, then 300 mW/cm2, and then 0 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Low, High Irradiance, Sham Middle Irradiance
Participants first receive t-PBM at irradiance doses of 50 mW/cm2, then 770 mW/cm2, then 0 mW/cm2, and then 300 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Low, Middle, High Irradiance, Sham
Participants first receive t-PBM at irradiance doses of 50 mW/cm2, then 300 mW/cm2, then 770 mW/cm2, and then 0 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Low, Middle Irradiance, Sham High Irradiance
Participants first receive t-PBM at irradiance doses of 50 mW/cm2, then 300 mW/cm2, then 0 mW/cm2, and then 770 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Low Irradiance, Sham High, Middle Irradiance
Participants first receive t-PBM at irradiance doses of 50 mW/cm2, then 0 mW/cm2, then 770 mW/cm2, and then 300 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Low Irradiance, Sham Middle, High Irradiance
Participants first receive t-PBM at irradiance doses of 50 mW/cm2, then 0 mW/cm2, then 300 mW/cm2, and then 770 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Sham, High, Middle, Low Irradiance
Participants first receive t-PBM at irradiance doses of 0 mW/cm2, then 770 mW/cm2, then 300 mW/cm2, and then 50 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Sham, High, Low, Middle Irradiance
Participants first receive t-PBM at irradiance doses of 0 mW/cm2, then 770 mW/cm2, then 50 mW/cm2, and then 300 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Sham, Middle, High, Low Irradiance
Participants first receive t-PBM at irradiance doses of 0 mW/cm2, then 300 mW/cm2, then 770 mW/cm2, and then 50 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Sham Middle, Low, High Irradiance
Participants first receive t-PBM at irradiance doses of 0 mW/cm2, then 300 mW/cm2, then 50 mW/cm2, and then 770 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Sham Low, High, Middle Irradiance
Participants first receive t-PBM at irradiance doses of 0 mW/cm2, then 50 mW/cm2, then 770 mW/cm2, and then 300 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.

Experimental: t-PBM at Sham Low, Middle, High Irradiance
Participants first receive t-PBM at irradiance doses of 0 mW/cm2, then 50 mW/cm2, then 300 mW/cm2, and then 770 mW/cm2
Device: Transcranial photobiomodulator
The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.




Primary Outcome Measures :
  1. Change of t-PBM effects on Blood Oxygen Level Dependent (BOLD) signal [ Time Frame: 12 weeks ]
    The specificity of t-PBM effects on Blood Oxygen Level Dependent(BOLD) signal increases will be assessed by testing three irradiance doses covering a wide range (50, 300 and 700 mW/cm2) versus sham. If a reliable effect on BOLD (compared to sham, the BOLD increase at the optimal dose will have an effect size of Cohen's d≥0.5) is seen with PBM, the study validate BOLD fMRI as a robust biomarker of target engagement for t-PBM and act as a "go" signal. In contrast, if none of the t-PBM doses yield reliable BOLD increases, this will fail the putative mechanism (no go).


Secondary Outcome Measures :
  1. Changes in the frequency of suicidal ideation experienced [ Time Frame: 4 visits over 4-8 weeks ]
    This will be measured by the Columbia Suicide Severity Rating Scale (C-SSRS), an instrument endorsed by the FDA for clinical trials. This instrument systematically tracks suicidal ideation and behavior. The C-SSRS is made up of ten categories, all of which maintain binary responses (yes/no) to indicate a presence or absence of the behavior. A yes/no binary response is also utilized in assessing self-injurious behavior without suicidal intent. The results of scoring will indicate the following: Suicidal ideation "Yes" Categories 1-5, Suicidal behavior "Yes" Categories 6-10 and Suicidal ideation & behavior "Yes" Categories 1-10

  2. Change in overall depression severity [ Time Frame: 4 visits over 4-8 weeks ]
    This will be measured by the use of Clinical Global Impressions - Severity (CGI-S). This instrument is scored 1-7 by the clinician based on assessment of the subject's overall clinical status. It will measure, based on history and scores on other instruments the overall depressive severity (CGI-S). The score of 1 indicates normal where as the score of 7 indicates extremely ill patients.

  3. Change in overall clinical improvement [ Time Frame: 4 visits over 4-8 weeks ]
    This will be assessed by using the Clinical Global Impressions - Improvement (CGI-I). The instrument is scored 1-7 by the clinician based on assessment of the subject's overall clinical status. It will measure, based on history and scores on other instruments the overall clinical improvement (CGI-I). The score of 1 indicates very much improved whereas the score of 7 indicates very much worse in clinical status

  4. Effectiveness of Blinding Process [ Time Frame: 4 visits over 4-8 weeks ]
    The effectiveness of the blinding process in this study will be assessed by the Perceptions of Blinding Questionnaire (PBQ). The PBQ is a self-report questionnaire to determine the degree to which the participant believes s/he is receiving the treatment or the sham.

  5. Change in the frequency of side effects experienced [ Time Frame: 4 visits over 4-8 weeks ]
    This will be measured by using the Systematic Assessment for Treatment Emergent Events (SAFTEE). The SAFTEE is a commonly used instrument originally developed by NIMH and adapted into a self-report instrument. This version of the scale examines in a systematic fashion all possible treatment-emergent side effects and probes specific adverse symptoms, including suicidal thoughts and behaviors, and self-injurious behavior.

  6. Changes in frequency of self reported side effects of t-PBM [ Time Frame: 4 visits over 4-8 weeks ]
    This will be measured by the t-PBM Self-Report Questionnaire (TSRQ). An open-ended questionnaire focusing on potential inconveniences and discomforts from the t-PBM administered after each experimental visit.


Other Outcome Measures:
  1. Change in depression severity in participants [ Time Frame: 4 visits over 4-8 weeks ]
    This will be measured with the Montgomery-Åsberg Depression Rating Scale (MADRS). This 10-item clinician-rated instrument measures depression severity. It will be administered with a structured interview guide. The time frame for this scale is the past 7 days. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.

  2. Change in participants with symptoms of depression [ Time Frame: 4 visits over 4-8 weeks ]
    This will be measured by the Symptoms of Depression Questionnaire (SDQ). This is a comprehensive measure of depression that includes the assessment of symptoms in the anxiety-depression spectrum. It assesses irritability, anger attacks, and anxiety symptoms together with the commonly considered symptoms of depression. Analysis of the factor structure of the SDQ identified 5 subscales, including one in the anxiety-depression spectrum, with adequate internal consistency and concurrent validity.

  3. Change in anxiety severity in participants [ Time Frame: 4 visits over 4-8 weeks ]
    This will be measured with Anxiety Symptoms Questionnaire (ASQ). This is a 17-item self-report questionnaire measuring the frequency and intensity of 17 symptoms of anxiety, including nervousness, worrying, irritability, trouble relaxing, insomnia, lack of energy, difficulty concentrating, somatic symptoms, and impairment in functioning due to anxiety.

  4. Change in the Participants' perceived quality of cognition [ Time Frame: 4 visits over 4-8 weeks ]
    This will be assessed with the Quality of Life in Neurological Disorders, Cognitive Section (Neuro-QoL). The cognitive section of the Neuro-QoL is an 8 item self-rated measure of both executive function and general concerns. It measures perceived difficulties in cognitive abilities (e.g., memory, attention, and decision making) or in the application of such abilities to everyday tasks (e.g., planning, organizing, calculating, remembering and learning).

  5. Change in Participants' perceived quality of life [ Time Frame: 4 visits over 4-8 weeks ]
    This is assessed by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). Participants rate their satisfaction with the following domains of activity: physical health, feelings, work, household duties, school/course work, leisure time activities, and social relations. Each item uses a 5-point scale ranging from 1 (very poor) to 5 (very good). A total score is derived from 14 items with a maximum score of 70 and with higher scores indicating greater life satisfaction and enjoyment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must be able to give written informed consent and follow study procedures
  • Participants must have major depressive disorder; all the following conditions need to be met to ensure presence of significant depression symptoms:

    1. Meeting diagnostic criteria for Major Depressive Disorder (MDD) in the past two weeks, at the DSM-5 Mini-International Neuropsychiatric Interview (MINI)
    2. Inventory for Depressive Symptomatology Clinician-rated (IDS-C) total score ≥23 at screening
    3. Depression symptoms are the primary target of treatment or treatment-seeking.
  • Women of child-bearing potential must agree to use adequate contraception
  • Participants taking medications or psychotherapy approved for the treatment of major depressive disorder will need to be stable for at least 8 weeks prior to screen

Exclusion Criteria:

  • Unwilling or unable to comply with study requirements
  • Participants who are judged to be at serious and imminent suicidal (C-SSRS≥4) or homicide risk, or currently in crisis such that inpatient hospitalization or other crisis management should take priority
  • History of any or psychotic or bipolar disorder
  • Alcohol or substance use disorder, post-traumatic stress disorder, obsessive-compulsive disorder and eating disorders within the preceding 12 months
  • History of dementia, traumatic brain injury (TBI), or neurological disorders affecting the brain, including any history of stroke.
  • Cognitive impairment significant as determined by the Montreal Cognitive Assessment (MOCA) <22
  • History of antisocial personality disorder, or any clinically significant personality trait that would, in the investigator's judgment, preclude safe study participation or impair ability to remain adherent with the treatment protocol.
  • History of significant treatment non-adherence or situations where the subjects are unlikely to adhere to treatment, in the opinion of the investigator
  • Pregnant (as confirmed by pregnancy test at screen) or nursing.
  • Currently undergoing device-based treatment for depression or taking medications for depression other than SSRIs or SNRIs.
  • Treatment resistance with failure to respond to more than two adequate treatments with FDA-approved antidepressant medications during current episode of major depressive disorder.
  • History of ECT in the last 12 months; lifetime history of VNS; lifetime treatment resistance to any FDA-approved device-based treatment for major depressive disorder; device-based interventions for depression will need to be discontinued at least 8 weeks prior to screen.
  • Serious, unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, hematologic disease; defined as any medical illness which is not well-controlled with standard-of-care medications
  • Clinically significant abnormal findings of laboratory parameters including urine toxicology screen for drugs of abuse or at physical examination
  • Clinical or laboratory evidence of uncontrolled hypothyroidism; if maintained on thyroid medication must be euthyroid for at least 1 month before screening.
  • Past intolerance or hypersensivity to t-PBM.
  • Significant skin conditions on the subject's scalp that are found in the area of the procedure sites.
  • Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment.
  • Any type of implants in the head, whose functioning might be affected by t-PBM.
  • Failure to meet standard MRI safety requirements as determined by the MRI Safety Checklist.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366258


Contacts
Layout table for location contacts
Contact: Ellen Krotow 631-488-0107 ellen.krotow@nyulangone.org
Contact: Dan Iosifescu, MD 646-754-5156 Dan.Iosifescu@nyulangone.org

Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Christopher Funes, MS    617-724-8780    cjfunes@mgh.harvard.edu   
Principal Investigator: Paolo Cassano, MD, PhD         
United States, New York
New York University Recruiting
New York, New York, United States, 10016
Contact: Ellen Krotow    631-488-0107    ellen.krotow@nyulangone.org   
Principal Investigator: Dan Iosifescu, MD         
Nathan Kline Institute Recruiting
Orangeburg, New York, United States, 10962
Contact: Kate Collins, pHd    845-398-6580    kate.collins@nki.rfmh.org   
Principal Investigator: Dan Iosifescu, MD         
Sponsors and Collaborators
NYU Langone Health
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Dan Iosifescu, MD NYU Langone Health
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04366258    
Other Study ID Numbers: 20-00217
1R61MH122647-01 ( U.S. NIH Grant/Contract )
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: The investigator who proposed to use the data and upon reasonable request. Requests should be directed to Dr. Kate Collins, PhD (email: Kate.Collins@nki.rfmh.org). To gain access, data requestors will need to sign a data access agreement.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by NYU Langone Health:
MDD, neuromodulation, transcranial photobiomodulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders