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 names:
- 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 names:
- 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 names:
- 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 names:
- 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 names:
- 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 names:
- 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 names:
- 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 names:
- 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 names:
- 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 names:
- 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 names:
- 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 names:
- 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 names:
- 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 names:
- 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 names:
- 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 names:
- 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 names:
- 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 names:
- 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 names:
- 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
|
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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 names:
- LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)
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Device: Sham
Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.
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Experimental t-PBM at Sham, Middle, High, Low Irradiance
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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
|
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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 names:
- 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 names:
- 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 names:
- 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 names:
- 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.
|