Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Cognition in Post-traumatic Stress Disorder (PTSD)
|ClinicalTrials.gov Identifier: NCT03209882|
Recruitment Status : Suspended (IRB issues pending solution)
First Posted : July 6, 2017
Last Update Posted : November 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Post-traumatic Stress Disorder (PTSD)||Device: TILS Device: sham||Not Applicable|
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 three 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Metabolism and Function in Post-traumatic Stress Disorder (PTSD)|
|Actual Study Start Date :||October 1, 2017|
|Actual Primary Completion Date :||October 15, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Six weekly sessions of TILS. The TILS will consist of applying light of a specific wavelength (1064 nm) using a laser diode supplied by Cell Gen Therapeutics, LLC (CG-5000 laser, HD Laser Center, Dallas, TX, USA). Each session will consist of totally 8 minutes, with eight 1-min cycles alternating between two locations on the right forehead. The laser power will be 3.4 Watts.
Continuous-wave laser of a specific wavelength (1064 nm) that will be directed to the right forehead. The laser diode is supplied by Cell Gen Therapeutics, LLC (CG-5000 laser, HD Laser Center, Dallas, TX, USA).
Other Name: Low-level laser therapy (LLLT)
Sham Comparator: Sham
One weekly session of sham. The sham session will be randomly assigned into the first two intervention visits. The sham will consist of using the same CG-5000 laser for totally 8 minutes, with eight 1-min cycles alternating between two locations on the right forehead. However, the laser power will be turned to be 0 Watts. Therefore the sham session will generate same instrumental sound as TILS, but the subjects won't receive any actual laser illumination.
Same aperture of CG-5000 laser (HD Laser Center, Dallas, TX, USA), but the laser power will be turned to be 0 Watts.
- Cerebral CCO changes in response to TILS/sham intervention [ Time Frame: 7 weeks ]Cerebral CCO changes measured by broadband NIRS during every TILS/sham intervention
- Cerebral hemodynamic changes in response to TILS/sham intervention [ Time Frame: 7 weeks ]Cerebral hemodynamic changes measured by broadband NIRS during every TILS/sham intervention
- Short-term memory scores [ Time Frame: 8 weeks ]Performance scores measured during three short-term memory tasks, namely delayed match-to-sample (DMS) task as well as digit forward/backward tasks.
- Prefrontal activations in short-term memory processing [ Time Frame: 8 weeks ]Prefrontal hemodynamic activations measured by functional NIRS during the three short-term memory tasks
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209882
|United States, Texas|
|Engineering Research Building (ERB), University of Texas Arlington|
|Arlington, Texas, United States, 76010|
|Principal Investigator:||Fenghua Tian, PhD||University of Texas at Arlington|