Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Metabolism and Function in Post-traumatic Stress Disorder (PTSD)
Phase: NA
Conditions: Post-traumatic Stress Disorder (PTSD)
Sponsor: The University of Texas at Arlington

Title: 
Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Cognition in Post-
traumatic Stress Disorder (PTSD) 
NCT number:  NCT03209882 
Date:   
05/15/2021 
 
 
 

Study Protocol 
Veterans with PTSD are recruited from local community. Potentially qualified veterans will first 
undergo a diagnostic clinical interview (visit 1). The PTSD symptom scores and other medical 
information collected in this visit will be reviewed immediately to determine whether eligibility 
criteria are met. Eligible individuals will be guided to go through an IRB-approved informed 
consent form that describes the study and the terms of potential participation in the study. If a 
person chooses to participate, s/he will be scheduled for an fNIRS screening (visit 2). This 
screening will confirm whether the veteran shows hypoactivations in the prefrontal cortex in the 
memory retrieval phase – a precondition for study inclusion.  
Table 1. Experimental protocol 
Aim 
Visit 
Task 
Evaluations & 
screening 
1 
Clinical evaluation and consenting 
2 
fNIRS scan 
Aim 1 
3−4 
Pre-treatment fNIRS scan 
Sham or TILS; bbNIRS measurement 
Post-treatment fNIRS scan 
Aim 2 
5−9 
Pre-treatment fNIRS scan 
TILS; bbNIRS measurement 
Post-treatment fNIRS scan 
Veterans who pass the initial evaluations and screening will be instructed to receive once weekly 
TILS treatment at the same light power for seven weeks (visits 3 − 9). In fact, we will administer 
a sham treatment and a TILS treatment in a randomized sequence during the first two weeks 
(visits 3 and 4) to determine any acute neurophysiological effects of TILS compared with those 
induced by sham. Specifically, these effects include: 1) the prefrontal metabolic/CCO changes 
measured by bbNIRS during the treatment; and 2) the incremental changes of prefrontal 
activations and scores from three neutral memory tasks, which will be measured by fNIRS before 
and after the treatment (i.e., post-treatment measures minus pre-treatment measures). Then, 
statistical analyses will be conducted to determine the acute neurophysiological effects of TILS 
compared with sham.  
After the first two sessions, we will administer another five TILS treatments to the veterans (visits 
5 – 9) with fNIRS and bbNIRS measurements taken in each visit. Thus, each veteran will receive 
a total of six TILS treatments. An iterative statistical analysis procedure will be implemented to 
determine the least number of TILS sessions that can stably up-regulate prefrontal activity, which 
will be considered as an optimal TILS dosage.