Photobiomodulation to Alter Cerebral Blood Flow and to Affect the Emotional Status of Patients With Major Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Major Depression, Anxiety Disorder, Post-Traumatic Stress Disorder, Substance Abuse Disorder

Intervention / Treatment
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* Device: Photobiomodulation with a super-luminous light emitting diode


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients must be right handed, between the ages of 18 and 60, and meet criterion for depression on a Structured Clinical Diagnostic Interview Enrollment will be made without regard to gender or ethnicity Patients who are receiving treatment for depression, either psychological or pharmacological, may continue their treatment during the time of the study, but will be asked to try not to alter their treatment from one month prior to the onset of the experiment until its conclusion. If they must alter their treatment, the patient will continue in the study for observation, but will be excluded from any follow-up statistical comparisons Exclusion Criteria: Past history of psychotic disorder (including schizophrenia or schizoaffective disorder Bipolar disorder Obsessive compulsive disorder) Substance abuse disorder that has been active with the past 6 months, A history of violent behavior A history of a past suicide gesture or attempt A history of current suicidal ideation A history of a neurological condition (e.g. epilepsy, traumatic brain injury, stroke) Pregnancy Current acute or chronic medical condition requiring a medications that has psychological side-effects Any person whom we judge to have an impaired decision-making capacity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Photobiomodulation with a super-luminous light emitting diode|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale |  | Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Anxiety Rating Scale |  | Before treatment, 2-weeks after treatment, and 4-weeks after treatment | 
| Hamilton Anxiety Rating Scale |  | Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major depressive disorder, anxiety disorders, treatments, photobiomodulation, near infra-red phototherapy, cerebral blood flow