search
Back to results

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

Primary Purpose

Post-traumatic Stress Disorder (PTSD)

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TILS
sham
Sponsored by
The University of Texas at Arlington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Post-traumatic Stress Disorder (PTSD) focused on measuring Transcranial infrared laser stimulation (TILS), Near-infrared spectroscopy (NIRS)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

One TILS, one sham, and then five TILS interventions

One sham, then six TILS interventions

Arm Description

Participants first received a TILS intervention, followed by a sham session one week later. Then, participants received another five weekly TILS interventions.

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

Outcomes

Primary Outcome Measures

Cerebral CCO Changes in Response to TILS and Sham
Cerebral CCO changes measured by broadband NIRS during six TILS interventions and one sham session.
Cerebral Hemodynamic Changes in Response to TILS and Sham
Cerebral hemodynamic changes measured by broadband NIRS during every TILS or sham session

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 30, 2017
Last Updated
June 30, 2021
Sponsor
The University of Texas at Arlington
Collaborators
University of Texas at Austin
search

1. Study Identification

Unique Protocol Identification Number
NCT03209882
Brief Title
Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Cognition in Post-traumatic Stress Disorder (PTSD)
Official Title
Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Metabolism and Function in Post-traumatic Stress Disorder (PTSD)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
IRB approval terminated
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 8, 2019 (Actual)
Study Completion Date
October 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas at Arlington
Collaborators
University of Texas at Austin

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder (PTSD)
Keywords
Transcranial infrared laser stimulation (TILS), Near-infrared spectroscopy (NIRS)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One TILS, one sham, and then five TILS interventions
Arm Type
Experimental
Arm Description
Participants first received a TILS intervention, followed by a sham session one week later. Then, participants received another five weekly TILS interventions.
Arm Title
One sham, then six TILS interventions
Arm Type
Experimental
Arm Description
Participants first received a sham session, followed by six weekly TILS sessions.
Intervention Type
Device
Intervention Name(s)
TILS
Other Intervention Name(s)
Low-level laser therapy (LLLT)
Intervention Description
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
Intervention Name(s)
sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cerebral CCO Changes in Response to TILS and Sham
Description
Cerebral CCO changes measured by broadband NIRS during six TILS interventions and one sham session.
Time Frame
7 weeks
Title
Cerebral Hemodynamic Changes in Response to TILS and Sham
Description
Cerebral hemodynamic changes measured by broadband NIRS during every TILS or sham session
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Short-term Memory Scores
Description
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.
Time Frame
8 weeks
Title
Prefrontal Activations in Short-term Memory Processing
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fenghua Tian, PhD
Organizational Affiliation
University of Texas at Arlington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Engineering Research Building (ERB), University of Texas Arlington
City
Arlington
State/Province
Texas
ZIP/Postal Code
76010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs