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

Cassano P, Cusin C, Mischoulon D, Hamblin MR, De Taboada L, Pisoni A, Chang T, Yeung A, Ionescu DF, Petrie SR, Nierenberg AA, Fava M, Iosifescu DV - Psychiatry J (2015)

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Depression Clinical & Research Program, Massachusetts General Hospital, Boston, MA 02114, USA.

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.

No MeSH data available.


Related in: MedlinePlus

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.
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fig1: 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.

Mentions: This single-site study was approved by the Massachusetts General Hospital (MGH) institutional review board (IRB); the Food and Drug Administration (FDA) confirmed that an Investigational Device Exemption (IDE) was not required, as the investigation entailed nonsignificant risks. The Harvard Psychiatry Department (Dupont-Warren Fellowship and Livingston Award), the Brain and Behavior Research Foundation (NARSAD Young Investigator Award), and PhotoThera Inc. sponsored this investigation. Subjects meeting the Diagnostic Statistical Manual-IV (DSM-IV) criteria for MDD, with at least moderate depression (Hamilton depression rating scale, HAM-D17 total score between 14 and 24), were included in the study after providing written informed consent. Subjects had failed at most one antidepressant medication and psychotherapy course (stable treatment for at least 6 and 8 weeks, resp.) during the current episode. Active substance use disorders (within prior 6 months), lifetime psychotic episodes, unstable medical illness, and active suicidal or homicidal ideation were exclusionary criteria. Subjects with head-implants, taking light-activated drugs, or having forehead skin conditions (e.g., rash or tattoo) were also excluded. In addition, subjects with implanted metal devices, severe claustrophobia, or weight above 275 lbs were excluded for MRI contraindications. Subjects were randomized to a 7-week double-blind sham-controlled treatment, involving three weeks of either NIR or sham exposures twice a week followed by crossover to three more weeks of the alternate exposure; that is, patients that were exposed to NIR during the first three weeks of the study were exposed to sham, after a washout week, and vice versa. At each treatment session, NIR light (NeuroThera, continuously emitting GaAlAs-laser, manufactured by PhotoThera Inc., with 808 ± 10 nm wavelength (or the same device acting as a sham), with active cooling, total power output 5 W, and verified with a power meter attached to a photodiode detector, Ophir NOVA, prior to the experimental sessions) was administered to the forehead bilaterally at four sites total (2 min per site, 3.3 cm lens piece aperture, 3 cm spot diameter, and 7.1 cm2 spot area). We decided to cover the forehead widely (4 sites) to extensively irradiate the prefrontal cortex without overlaps; the data on safety from the NEST 1, NEST 2, and NEST 3 studies on stroke for our same instrument showed that irradiation of up to 20 sites on the scalp was safe (2 min each) [18–21]. Our parameters (including the localization to the forehead) were somewhat consistent with those of Schiffer and colleagues [17], which had demonstrated clinical efficacy of a single session of NIR in depression. NIR was administered with an irradiance of approximately 700 mW/cm2 and a fluence of 84 J/cm2 (same parameters as in NEST 1, NEST 2, and NEST 3) for a total NIR energy of 2.40 kJ delivered per session with the devices' actively cooled sapphire output lens in direct skin contact. See Table 1 for a summary of the NIR parameters used for this study and comparable studies of transcranial laser therapy (TLT). See Figure 1 for the picture of the handheld portion of the NeuroThera device. No additional information was provided by the manufacturer.


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

Cassano P, Cusin C, Mischoulon D, Hamblin MR, De Taboada L, Pisoni A, Chang T, Yeung A, Ionescu DF, Petrie SR, Nierenberg AA, Fava M, Iosifescu DV - Psychiatry J (2015)

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.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4556873&req=5

fig1: 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.
Mentions: This single-site study was approved by the Massachusetts General Hospital (MGH) institutional review board (IRB); the Food and Drug Administration (FDA) confirmed that an Investigational Device Exemption (IDE) was not required, as the investigation entailed nonsignificant risks. The Harvard Psychiatry Department (Dupont-Warren Fellowship and Livingston Award), the Brain and Behavior Research Foundation (NARSAD Young Investigator Award), and PhotoThera Inc. sponsored this investigation. Subjects meeting the Diagnostic Statistical Manual-IV (DSM-IV) criteria for MDD, with at least moderate depression (Hamilton depression rating scale, HAM-D17 total score between 14 and 24), were included in the study after providing written informed consent. Subjects had failed at most one antidepressant medication and psychotherapy course (stable treatment for at least 6 and 8 weeks, resp.) during the current episode. Active substance use disorders (within prior 6 months), lifetime psychotic episodes, unstable medical illness, and active suicidal or homicidal ideation were exclusionary criteria. Subjects with head-implants, taking light-activated drugs, or having forehead skin conditions (e.g., rash or tattoo) were also excluded. In addition, subjects with implanted metal devices, severe claustrophobia, or weight above 275 lbs were excluded for MRI contraindications. Subjects were randomized to a 7-week double-blind sham-controlled treatment, involving three weeks of either NIR or sham exposures twice a week followed by crossover to three more weeks of the alternate exposure; that is, patients that were exposed to NIR during the first three weeks of the study were exposed to sham, after a washout week, and vice versa. At each treatment session, NIR light (NeuroThera, continuously emitting GaAlAs-laser, manufactured by PhotoThera Inc., with 808 ± 10 nm wavelength (or the same device acting as a sham), with active cooling, total power output 5 W, and verified with a power meter attached to a photodiode detector, Ophir NOVA, prior to the experimental sessions) was administered to the forehead bilaterally at four sites total (2 min per site, 3.3 cm lens piece aperture, 3 cm spot diameter, and 7.1 cm2 spot area). We decided to cover the forehead widely (4 sites) to extensively irradiate the prefrontal cortex without overlaps; the data on safety from the NEST 1, NEST 2, and NEST 3 studies on stroke for our same instrument showed that irradiation of up to 20 sites on the scalp was safe (2 min each) [18–21]. Our parameters (including the localization to the forehead) were somewhat consistent with those of Schiffer and colleagues [17], which had demonstrated clinical efficacy of a single session of NIR in depression. NIR was administered with an irradiance of approximately 700 mW/cm2 and a fluence of 84 J/cm2 (same parameters as in NEST 1, NEST 2, and NEST 3) for a total NIR energy of 2.40 kJ delivered per session with the devices' actively cooled sapphire output lens in direct skin contact. See Table 1 for a summary of the NIR parameters used for this study and comparable studies of transcranial laser therapy (TLT). See Figure 1 for the picture of the handheld portion of the NeuroThera device. No additional information was provided by the manufacturer.

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Depression Clinical & Research Program, Massachusetts General Hospital, Boston, MA 02114, USA.

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.

No MeSH data available.


Related in: MedlinePlus