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

Post-traumatic Stress Disorder (PTSD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03209882
• Other study ID #: 2017-0512
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: October 8, 2019

Study information

• Verified date: June 2021
• Source: The University of Texas at Arlington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 8, 2019
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• TILS
Continuous-wave laser of a specific wavelength (1064 nm) was administered to the participants' right forehead for 8 minutes. The laser power was 3.4 Watts.
• sham
The sham session consisted of administering the same laser to the participants' right forehead for totally 8 minutes. However, the laser power was turned to be 0 Watts.

Locations

Country	Name	City	State
United States	Engineering Research Building (ERB), University of Texas Arlington	Arlington	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas at Arlington	University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral CCO Changes in Response to TILS and Sham	Cerebral CCO changes measured by broadband NIRS during six TILS interventions and one sham session.	7 weeks
Primary	Cerebral Hemodynamic Changes in Response to TILS and Sham	Cerebral hemodynamic changes measured by broadband NIRS during every TILS or sham session	7 weeks
Secondary	Short-term Memory Scores	The participant's recall time in Digit Forward (DF) task and Digit Backward (DB) task was recorded recorded during initial baseline, and after the one sham and six TILS sessions.; The recall time indicates how fast the participants could recall that digital numbers 10 seconds after they vanished on computer screen.	8 weeks
Secondary	Prefrontal Activations in Short-term Memory Processing	Anterior prefrontal hemodynamic activations (HbO2 and Hb changes) measured by functional NIRS during the Digit Forward (DF) and Digit Backward (DB) tasks. The activations were recorded from initial baseline, and after the one sham and six TILS sessions. In post-experiment processing, the activations were averaged in the recall phase, which was a key component related to PTSD.	8 weeks