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

Post-Traumatic Stress Disorder Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961454
• Other study ID #: 2008P-000937
• Status: Completed
• Phase: Phase 1
• First received: August 18, 2009
• Last updated: August 18, 2009
• Start date: January 2009
• Est. completion date: June 2009

Study information

• Verified date: August 2009
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depression
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance Abuse Disorder
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Wellman Center for Photomedicine, Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale		Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment	Yes
Secondary	Hamilton Anxiety Rating Scale		Before treatment, 2-weeks after treatment, and 4-weeks after treatment	Yes
Secondary	Hamilton Anxiety Rating Scale		Before treatment (baseline), 2-weeks after treatment, and 4-weeks after treatment.	Yes