Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Cognition in Post-traumatic Stress Disorder (PTSD)
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|ClinicalTrials.gov Identifier: NCT03209882|
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : July 10, 2018
|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)|
|Estimated Enrollment :||100 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|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209882
|Contact: Fenghua Tian, PhDemail@example.com|
|Contact: Robert J Gatchel, PhDfirstname.lastname@example.org|
|United States, Texas|
|Life Science Building, Department of Psychology at the University of Texas Arlington||Recruiting|
|Arlington, Texas, United States, 76019|
|Contact: Robert Gatchel, Ph.D 817-272-2541 email@example.com|
|Principal Investigator:||Fenghua Tian, PhD||University of Texas at Arlington|