Table 1.
Summary of the NIR parameters used for this study (Cassano et al.) and other comparison studies.
| Cassano et al. (this study) |
Schiffer et al., 2009 [17] | Barrett and Gonzalez-Lima, 2013 [13] | Naeser et al., 2014 [15] | |
|---|---|---|---|---|
| Study design | Pilot, open | Open | Double-blind randomized NIR versus sham |
Open |
|
| ||||
| Subjects enrolled | 4 MDD completers |
10 resistant MDD |
40 psychology undergraduates |
11 chronic TBI (8 cases with depression; 5 with at least moderate severity) |
|
| ||||
| Number of treatment sessions | 2/week for 3 weeks |
1 | 1 | 3/week for 6 weeks |
|
| ||||
| Duration of clinical follow-up | 8 weeks | 4 weeks | 2 weeks | 14 weeks |
|
| ||||
| Clinical outcome(s) | 50% remission of MDD at weeks 6-7 (HAM-D17 ≤7) |
60% remission of MDD at week 2 (HAM-D-21 <10) |
Maintained positive affect at 2 weeks compared to decline of control group (PANAS) | 37% response of depression at week 7 (decrease of BDI-II total score ≥50% from baseline) |
|
| ||||
| Device specifications | ||||
| Manufacturer/model/type | PhotoThera/NeuroThera/laser diode | Custom device/Marubeni America Corp./LED | Cell Gen Therapeutics/Model CG-5000/laser diode | MedX Health/Model 1100/LED |
| Wavelength (nm) | 808 | 810 | 1064 | 870 and 633 |
| Spot diameter (cm) | 3 | — | 4 | 5.35 |
| Spot area (cm2) | 7.1 | ~1 | 12.6 | 22.5 |
|
| ||||
| Site exposure parameters | ||||
| Time (sec) | 120 | 240 | 240 | 585 |
| Irradiance (mW/cm2) | 700 | 250 | 250 | 22.2 |
| Fluence (J/cm2) | 84 | 60 | 60 | 13 |
|
| ||||
| Treatment exposure parameters | ||||
| Number of exposed sites | Four | Two | Two | Eleven |
| Site locations, transcranial treatments | Bilateral (R and L forehead center at 20 and 40 mm from sagittal line) | Bilateral (R and L forehead at EEG map sites: F3, F4) | Unilateral (R, frontal pole on 4 cm medial and lateral) | Midline and bilateral (forehead (prefrontal) and temporal, parietal, and occipital area) |
| Total area exposed (“treatment window,” cm2) | 28.4 (7.1 × 4 sites) | 2 (1 × 2 sites) | 25.2 (12.6 × 2 sites) | 247 (22.5 × 11 sites) |
| Total energy delivered, per session (kJ) | 2.4 (0.6 × 4 sites) | 0.12 (0.06 × 2 sites) | 1.51 (0.76 × 2 sites) | 3.21 (0.29 × 11 sites) |
| Total energy delivered, per treatment (kJ) | 14.4 (total energy per session × 2 sessions/week × 3 weeks) |
0.12 (total energy per session × 1 session) | 1.51 (total energy per session × 1 session) | 57.87 (total energy per session × 3 sessions/week × 6 weeks) |