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NCT Number: NCT00961454

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wellman Center for Photomedicine, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photobiomodulation with a super-luminous light emitting diode

Device

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.

Other names: Near infra-red light

Primary outcomes

  1. Hamilton Depression Rating Scale

    Time frame: Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment

Secondary outcomes

  1. Hamilton Anxiety Rating Scale

    Time frame: Before treatment, 2-weeks after treatment, and 4-weeks after treatment

  2. Hamilton Anxiety Rating Scale

    Time frame: Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 19, 2009
Registry last updated
Aug 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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