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

NCT ID: NCT03209882

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-10-08

Brief 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.

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.

Conditions

Post-traumatic Stress Disorder (PTSD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

TILS

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

One sham, then six TILS interventions

Participants first received a sham session, followed by six weekly TILS sessions.

Group Type: EXPERIMENTAL

TILS

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Low-level laser therapy (LLLT)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: collaborator

The University of Texas at Arlington

OTHER

Sponsor Role: lead

Responsible Party

Fenghua Tian, PhD

Assistant Professor of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fenghua Tian, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Arlington

Locations

Engineering Research Building (ERB), University of Texas Arlington

Arlington, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-0512

Identifier Type: -

Identifier Source: org_study_id