Wellman Center for Photomedicine, Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT00961454
A pilot study to evaluate the ability of photobiomodulation to alter cerebral blood flow in the frontal poles and to affect the emotional status of patients with major depression.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Boston, Massachusetts, 02114, United States
We wish to study whether photobiomodulation (PBM) with near infrared (NIR) light emitting diodes (LED), a non-ionizing phototherapy, in patients with major depression, can acutely alter frontal brain blood flow measured by near infrared spectroscopy (NIRS).
Secondarily, we will examine whether PBM can improve emotional state immediately and over the following month.
We see this as a pilot study to gather preliminary data that will guide future studies.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The treatment will consist of applying PBM in the form of a super-luminous LED with an output of 250 mW/cm2 at a wavelength of 815 nm with a full width half maximum of 40 nm when applied at 4 mm from the skin. The treatment will consist of the exposure to the light for 4 minutes (total delivered fluence per spot of 60 J/cm2) at each of 4 sites on the forehead that correspond to the 10-20 EEG sites, F3, and F4.
Other names: Near infra-red light
Time frame: Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment
Time frame: Before treatment, 2-weeks after treatment, and 4-weeks after treatment
Time frame: Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment.
Massachusetts General Hospital
Other
A Pilot Study to Evaluate the Ability of Photobiomodulation to Alter Cerebral Blood Flow in the Frontal Poles and to Affect the Emotional Status of Patients With Major Depression
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