96
Participants
Start Date
January 9, 2015
Primary Completion Date
August 6, 2018
Study Completion Date
August 6, 2018
Real LED Treatment
"PhotoMedex Helmet: 12 Pods, 4.5 x 4.8cm (21.6 cm2); 20 diodes; 830nm; Power Output (PO) 665.3 mW; Power Density (PD)/LED 30.8 mW/cm2; CW; Time/session 28m 10s\*; Dose: Energy Density 26 J/cm2.~MedX Device: 1 Cluster Head/ear, 2 inch diameter (22.48 cm2); 870nm; PO 90 mW; PD/LED 4 mW/cm2; CW; Time/session 4m; Energy Density 4 J/cm2; 2 Vielight Intranasal Devices: Red, 633nm diode; PO 6.5 mW; PD/LED 7.6 mW/cm2; CW; Time/session 25m; Energy Density 11.4 J/cm2 and NIR, 810nm diode; PO 6.5 mW; PD/LED 7.6 mW/cm2; Pulse frequency 10Hz; Duty Cycle 50%; Time/session 25m; Energy Density 11.4 J/cm2 Thor Photomedicine Helmet: 10 Pods, 6cm diameter (28.3 cm2); 35 diodes; Wavelength 850nm; PO 1050 mW; PD/LED 50 mW/cm2; CW; Time/session 23m, 24s; Energy Density 26 J/cm2 2 Placement sets: 1) midline, 6 cluster heads; 2) L\&R side of head 12 cluster heads (14m, 5s, each set); 1) midline, 5 cluster heads; 2) L\&R side of head 10 cluster heads (11m, 42s, each set) CW, Continuous Wave"
Sham LED Treatment
Intervention for Real and Sham are Identical, but sham has power output of 0, no photons emitted.
San Francisco VA Medical Center, San Francisco, CA, San Francisco
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston
VA Office of Research and Development
FED