Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Cognition in Post-traumatic Stress Disorder (PTSD)

The University of Texas System (UT)

Status: Terminated

Conditions: Post-traumatic Stress Disorder (PTSD)

Treatments: Device: TILS; Device: sham

Study type: Interventional

Funder types: Other

Identifiers

NCT03209882

2017-0512

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups

One TILS, one sham, and then five TILS interventions

Experimental group

Description:

Participants first received a TILS intervention, followed by a sham session one week later. Then, participants received another five weekly TILS interventions.

Treatment:

Device: TILS

Device: sham

One sham, then six TILS interventions

Experimental group

Description:

Participants first received a sham session, followed by six weekly TILS sessions.

Treatment:

Device: TILS

Device: sham