Clinical trial NCT03209882: Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Cognition in Post-traumatic Stress Disorder (PTSD)
Official title: Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Metabolism and Function in Post-traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-traumatic Stress Disorder (PTSD)
Keywords: Transcranial infrared laser stimulation (TILS)
Near-infrared spectroscopy (NIRS)
Lead sponsor: The University of Texas at Arlington
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
First posted: 2017-07-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cerebral CCO Changes in Response to TILS and Sham
timeFrame: 7 weeks
measure: Cerebral Hemodynamic Changes in Response to TILS and Sham
timeFrame: 7 weeks
Secondary outcomes:
measure: Short-term Memory Scores
timeFrame: 8 weeks
measure: Prefrontal Activations in Short-term Memory Processing
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Arlington
country: United States
facility: Engineering Research Building (ERB), University of Texas Arlington
state: Texas
Study officials:
affiliation: University of Texas at Arlington
name: Fenghua Tian, PhD
role: PRINCIPAL_INVESTIGATOR
References: