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

NCT ID: NCT00961454

Last Updated: 2009-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-06-30

Brief 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.

Detailed 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.

Conditions

Major Depression; Anxiety Disorder; Post-Traumatic Stress Disorder; Substance Abuse Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Near infra-red light

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Massachusetts General Hospital

Principal Investigators

Fredric - Schiffer, M.D.

Role: STUDY_DIRECTOR

McLean Hospital and the Harvard Medical School

Robert H Webb, Ph.D.

Role: STUDY_CHAIR

Massachusetts General Hospital

Andrea Johnston, BA

Role: STUDY_CHAIR

Massachusetts General Hospital

Martin H Teicher, M.D., Ph.D.

Role: STUDY_CHAIR

Mclean Hospital

Locations

Wellman Center for Photomedicine, Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Schiffer F, Johnston AL, Ravichandran C, Polcari A, Teicher MH, Webb RH, Hamblin MR. 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. Behav Brain Funct. 2009 Dec 8;5:46. doi: 10.1186/1744-9081-5-46.

Reference Type: DERIVED

PMID: 19995444 (View on PubMed)

Other Identifiers

2008P-000937

Identifier Type: -

Identifier Source: org_study_id