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

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

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.

Study Overview

• Status: Terminated
• Conditions: Post-traumatic Stress Disorder (PTSD)
• Intervention / Treatment: Device: TILS; Device: sham

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Arlington, Texas, United States, 76010
      • Engineering Research Building (ERB), University of Texas Arlington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One TILS, one sham, and then five TILS interventions; Participants first received a TILS intervention, followed by a sham session one week later. Then, participants received another five weekly TILS interventions.	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.; Other Names: Low-level laser therapy (LLLT); Device: 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.
Experimental: One sham, then six TILS interventions; Participants first received a sham session, followed by six weekly TILS sessions.	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.; Other Names: Low-level laser therapy (LLLT); Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: The University of Texas at Arlington
• Collaborators: University of Texas at Austin
• Investigators: Principal Investigator: Fenghua Tian, PhD, University of Texas at Arlington

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): October 8, 2019
• Study Completion (Actual): October 8, 2019

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Near-infrared spectroscopy (NIRS); Transcranial infrared laser stimulation (TILS)
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2017-0512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Phenotypic data collected from the subjects and secondary analysis of data (if any) will be deposited at the National Database for Clinical Trials related to Mental Illness (NDCT; http://ndct.nimh.nih.gov/). It will include data collected from the subjects' forehead with optical neuroimaging modalities as well as the subjects' performance scores in three short-term memory tasks. Additional data documentation and de-identified data will be deposited for sharing along with phenotypic data, which includes demographics and PTSD scores.
• IPD Sharing Time Frame: Six months after completion of the project
• IPD Sharing Access Criteria: Investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes in PTSD diagnosis and therapy.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No