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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
Sponsor:
Collaborator:
University of Texas at Austin
Information provided by (Responsible Party):
Fenghua Tian, The University of Texas at Arlington

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.

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder (PTSD) Device: TILS Device: sham Not Applicable

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TILS
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.
Device: TILS
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.
Device: sham
Same aperture of CG-5000 laser (HD Laser Center, Dallas, TX, USA), but the laser power will be turned to be 0 Watts.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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), risk of suicide (PHQ-9, Item 9 >0), severe headache (PHQ-15, Item e >0), and/or severe dizziness (PHQ-15, Item g >0)
  • Opiate use in the month prior to study entry

Information from the National Library of Medicine

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


Contacts
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Contact: Fenghua Tian, PhD 817-807-5271 fenghua.tian@uta.edu
Contact: Robert J Gatchel, PhD 817-272-2541 gatchel@uta.edu

Locations
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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    gatchel@uta.edu   
Sponsors and Collaborators
The University of Texas at Arlington
University of Texas at Austin
Investigators
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Principal Investigator: Fenghua Tian, PhD University of Texas at Arlington

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Responsible Party: Fenghua Tian, Faculty Associate Researcher, The University of Texas at Arlington
ClinicalTrials.gov Identifier: NCT03209882     History of Changes
Other Study ID Numbers: 2017-0512
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Six months after completion of the project
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Fenghua Tian, The University of Texas at Arlington:
Transcranial infrared laser stimulation (TILS)
Near-infrared spectroscopy (NIRS)

Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders