Print

Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
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.
Primary Purpose
Diagnostic
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • 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, 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 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.

Recruiting Locations

Massachusetts General Hospital
Charlestown, Massachusetts 02129
Contact:
Christopher Funes, MS
617-724-8780
cjfunes@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

Ellen Krotow
631-488-0107
ellen.krotow@nyulangone.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.