IRB approval terminated

This study evaluates the effects of transcranial infrared laser stimulation (TILS) on prefrontal metabolism and hemodynamics in veterans with post-traumatic stress disorder (PTSD). The subjects will receive six TILS interventions and one sham intervention in a course of seven weeks.

Post-traumatic stress disorder (PTSD) is often associated with cognitive impairments. It has been indicated that hypoactivity of the prefrontal cortex plays a major role in the disrupted neural circuitry of mood and cognition.

Transcranial infrared laser stimulation (TILS) is a neural type of photobiomodulation that can elevate neuronal metabolism by exciting cytochrome c oxidase (CCO). Veterans with PTSD will receive prefrontal TILS interventions once-per-week for six weeks. They will also receive an additional sham intervention (laser power = 0) that will be randomly assigned into the first two sessions. Broadband near-infrared spectroscopy (bbNIRS) will be used to directly assess the CCO changes during every TILS/sham session.

Veterans' prefrontal functions will be evaluated with short-term memory tasks before and after each intervention. The prefrontal activities will also be imaged by functional near-infrared spectroscopy (fNIRS) to objectively assess the functional changes due to TILS/sham interventions.

Inclusion Criteria:

• War-zone and non-war-zone veterans
• Ages 18-60 years old
• Males and females
• Able to read, speak, and understand English
• Medical records showing prior diagnosis of PTSD (here it refers to the records prior to TILS, which will be assessed and obtained in Visit 1)
• Medical records showing diagnosis of PTSD (here it refers to the CAPS-5 record prior to TILS, which will be assessed and obtained in Visit 1)
• On stable doses of any psychotropic medications for at least 4 weeks

Exclusion Criteria:

• Significant physical disability to perform a computerized memory task
• Past/current significant medical/neurological/mental health disorders known to affect cognitive functioning (e.g., stroke, dementia, schizophrenia, AIDS)
• Presence of moderate/severe TBI, defined as having: alteration of consciousness/mental state >24 hours; posttraumatic amnesia >1 day; loss of consciousness >30 minutes; and/or abnormal structural neuroimaging. We will not exclude veterans with mild TBI, which is found in nearly 50% of veterans with PTSD
• Alcohol abuse/dependence for the past 12- months, as determined by the Rapid Alcohol Problems Screen score >0
• Drug abuse/dependence for the past 12- months, as determined by the Drug Abuse Screening Test-10 score >2
• Severe depression (PHQ-9 total score >19), significant risk of suicide (SBQ-R >6), severe headache (PHQ-15, Item e =2), and/or severe dizziness (PHQ-15, Item g =2)
• Opiate use in the month prior to study entry

Phenotypic data collected from the subjects and secondary analysis of data (if any) will be deposited at the National Database for Clinical Trials related to Mental Illness (NDCT; http://ndct.nimh.nih.gov/). It will include data collected from the subjects' forehead with optical neuroimaging modalities as well as the subjects' performance scores in three short-term memory tasks. Additional data documentation and de-identified data will be deposited for sharing along with phenotypic data, which includes demographics and PTSD scores.

Six months after completion of the project

Investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes in PTSD diagnosis and therapy.

Entire course of TILS/sham sessions (7 weeks).

The subjects were closely monitored in regard to physical reactions to TILS, and worsening symptoms. A 10-level VAS scale was used to measure headache and dizziness following each TILS/sham session. Severe reaction was defined as VAS ≥5. Then, the subjects were assessed for worsening PTSD symptoms (an increase of ≥24 points in Mississippi-Military), severe depression (PHQ-9 > 19), risk of suicide(SBQ-R ≥ 7).