Near-Infrared Transcranial Radiation for Major Depressive Disorder: Proof of Concept Study

Paolo Cassano, Cristina Cusin, David Mischoulon, Michael R Hamblin, Luis De Taboada, Angela Pisoni, Trina Chang, Albert Yeung, Dawn F Ionescu, Samuel R Petrie, Andrew A Nierenberg, Maurizio Fava, Dan V Iosifescu, Paolo Cassano, Cristina Cusin, David Mischoulon, Michael R Hamblin, Luis De Taboada, Angela Pisoni, Trina Chang, Albert Yeung, Dawn F Ionescu, Samuel R Petrie, Andrew A Nierenberg, Maurizio Fava, Dan V Iosifescu

Abstract

Transcranial near-infrared radiation (NIR) is an innovative treatment for major depressive disorder (MDD), but clinical evidence for its efficacy is limited. Our objective was to investigate the tolerability and efficacy of NIR in patients with MDD. We conducted a proof of concept, prospective, double-blind, randomized study of 6 sessions of NIR versus sham treatment for patients with MDD, using a crossover design. Four patients with MDD with mean age 47 ± 14 (SD) years (1 woman and 3 men) were exposed to irradiance of 700 mW/cm(2) and a fluence of 84 J/cm(2) for a total NIR energy of 2.40 kJ delivered per session for 6 sessions. Baseline mean HAM-D17 scores decreased from 19.8 ± 4.4 (SD) to 13 ± 5.35 (SD) after treatment (t = 7.905; df = 3; P = 0.004). Patients tolerated the treatment well without any serious adverse events. These findings confirm and extend the preliminary data on NIR as a novel intervention for patients with MDD, but further clinical trials are needed to better understand the efficacy of this new treatment. This trial is registered with ClinicalTrials.gov NCT01538199.

Figures

Figure 1
Figure 1
The picture shows the handheld portion of the NeuroThera device, which is pressed against the forehead of the subject. A paper band is used to locate the sites of irradiation across the forehead. Prior to irradiation on each site, the corresponding area of skin is exposed by peeling off the overlying circle of paper from the band.
Figure 2
Figure 2
Mean and individual HAM-D17 total score ((a) and (b), resp.) for the 4 MDD subjects who sequentially received transcranial NIR and sham. All 4 treatment-completers had received NIR from week 0 to week 3.

References

    1. Yu W., Naim J. O., McGowan M., Ippolito K., Lanzafame R. J. Photomodulation of oxidative metabolism and electron chain enzymes in rat liver mitochondria. Photochemistry and Photobiology. 1997;66(6):866–871. doi: 10.1111/j.1751-1097.1997.tb03239.x.
    1. Mochizuki-Oda N., Kataoka Y., Cui Y., Yamada H., Heya M., Awazu K. Effects of near-infra-red laser irradiation on adenosine triphosphate and adenosine diphosphate contents of rat brain tissue. Neuroscience Letters. 2002;323(3):207–210. doi: 10.1016/s0304-3940(02)00159-3.
    1. Oron U., Ilic S., De Taboada L., Streeter J. Ga-As (808 nm) laser irradiation enhances ATP production in human neuronal cells in culture. Photomedicine and Laser Surgery. 2007;25(3):180–182. doi: 10.1089/pho.2007.2064.
    1. Wong-Riley M. T. T., Liang H. L., Eells J. T., et al. Photobiomodulation directly benefits primary neurons functionally inactivated by toxins: role of cytochrome c oxidase. Journal of Biological Chemistry. 2005;280(6):4761–4771. doi: 10.1074/jbc.m409650200.
    1. Giuliani A., Lorenzini L., Gallamini M., Massella A., Giardino L., Calzà L. Low infra red laser light irradiation on cultured neural cells: effects on mitochondria and cell viability after oxidative stress. BMC Complementary and Alternative Medicine. 2009;9, article 8 doi: 10.1186/1472-6882-9-8.
    1. Rojas J. C., Lee J., John J. M., Gonzalez-Lima F. Neuroprotective effects of near-infrared light in an in vivo model of mitochondrial optic neuropathy. Journal of Neuroscience. 2008;28(50):13511–13521. doi: 10.1523/JNEUROSCI.3457-08.2008.
    1. Eells J. T., Henry M. M., Summerfelt P., et al. Therapeutic photobiomodulation for methanol-induced retinal toxicity. Proceedings of the National Academy of Sciences of the United States of America. 2003;100(6):3439–3444. doi: 10.1073/pnas.0534746100.
    1. Ando T., Xuan W., Xu T., et al. Comparison of therapeutic effects between pulsed and continuous wave 810-nm wavelength laser irradiation for traumatic brain injury in mice. PLoS ONE. 2011;6(10) doi: 10.1371/journal.pone.0026212.e26212
    1. Wu Q., Xuan W., Ando T., et al. Low-level laser therapy for closed-head traumatic brain injury in mice: effect of different wavelengths. Lasers in Surgery and Medicine. 2012;44(3):218–226. doi: 10.1002/lsm.22003.
    1. Oron A., Oron U., Streeter J., et al. Low-level laser therapy applied transcranially to mice following traumatic brain injury significantly reduces long-term neurological deficits. Journal of Neurotrauma. 2007;24(4):651–656. doi: 10.1089/neu.2006.0198.
    1. Xuan W., Vatansever F., Huang L., et al. Transcranial low-level laser therapy improves neurological performance in traumatic brain injury in mice: effect of treatment repetition regimen. PLoS ONE. 2013;8(1) doi: 10.1371/journal.pone.0053454.e53454
    1. Michalikova S., Ennaceur A., van Rensburg R., Chazot P. L. Emotional responses and memory performance of middle-aged CD1 mice in a 3D maze: effects of low infrared light. Neurobiology of Learning and Memory. 2008;89(4):480–488. doi: 10.1016/j.nlm.2007.07.014.
    1. Barrett D. W., Gonzalez-Lima F. Transcranial infrared laser stimulation produces beneficial cognitive and emotional effects in humans. Neuroscience. 2013;230:13–23. doi: 10.1016/j.neuroscience.2012.11.016.
    1. Naeser M. A., Saltmarche A., Krengel M. H., Hamblin M. R., Knight J. A. Improved cognitive function after transcranial, light-emitting diode treatments in chronic, traumatic brain injury: two case reports. Photomedicine and Laser Surgery. 2011;29(5):351–358. doi: 10.1089/pho.2010.2814.
    1. Naeser M. A., Zafonte R., Krengel M. H., et al. Significant improvements in cognitive performance post-transcranial, red/near-infrared light-emitting diode treatments in chronic, mild traumatic brain Injury: open-protocol study. Journal of Neurotrauma. 2014;31(11):1008–1017. doi: 10.1089/neu.2013.3244.
    1. Morries L. D., Cassano P., Henderson T. A. Treatments for traumatic brain injury with emphasis on transcranial near-infrared laser phototherapy. In press.
    1. Schiffer F., Johnston A. L., Ravichandran C., et al. Psychological benefits 2 and 4 weeks after a single treatment with near infrared light to the forehead: a pilot study of 10 patients with major depression and anxiety. Behavioral and Brain Functions. 2009;5(1, article 46) doi: 10.1186/1744-9081-5-46.
    1. Zivin J. A., Sehra R., Shoshoo A., et al. NeuroThera Efficacy and Safety Trial-3 (NEST-3): a double-blind, randomized, sham-controlled, parallel group, multicenter, pivotal study to assess the safety and efficacy of transcranial laser therapy with the NeuroThera Laser System for the treatment of acute ischemic stroke within 24 h of stroke onset. International Journal of Stroke. 2014;9(7):950–955. doi: 10.1111/j.1747-4949.2012.00896.x.
    1. Hacke W., Schellinger P. D., Albers G. W., et al. Transcranial laser therapy in acute stroke treatment: results of neurothera effectiveness and safety trial 3, a phase III clinical end point device trial. Stroke. 2014;45(11):3187–3193. doi: 10.1161/strokeaha.114.005795.
    1. Lampl Y., Zivin J. A., Fisher M., et al. Infrared laser therapy for ischemic stroke: a new treatment strategy. Results of the NeuroThera Effectiveness and Safety Trial-1 (NEST-1) Stroke. 2007;38(6):1843–1849. doi: 10.1161/strokeaha.106.478230.
    1. Huisa B. N., Stemer A. B., Walker M. G., Rapp K., Meyer B. C., Zivin J. A. Transcranial laser therapy for acute ischemic stroke: a pooled analysis of NEST-1 and NEST-2. International Journal of Stroke. 2013;8(5):315–320. doi: 10.1111/j.1747-4949.2011.00754.x.
    1. Guy W., Wilson W. H., Brooking B., Manov G., Fjetland O. Reliability and validity of SAFTEE: preliminary analyses. Psychopharmacology Bulletin. 1986;22(2):397–401.
    1. Tuner J., Jenkins P. Complications in comparing lasers and LED. Comment on Esper MA, Nicolau RA, Arisawa EA (2011) The effect of two phototherapy protocols on pain control in orthodontic procedure—a preliminary clinical study. Lasers Med Sci 26:657-663. Lasers in Medical Science. 2012;27(6):1257–1258.
    1. Zivin J. A., Albers G. W., Bornstein N., et al. Effectiveness and safety of transcranial laser therapy for acute ischemic stroke. Stroke. 2009;40(4):1359–1364. doi: 10.1161/strokeaha.109.547547.

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren