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

NCT03209882 | Terminated Results FDA Device

• 1 other identifier: 2017-0512
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Stress Disorder (PTSD)

Keywords

Transcranial infrared laser stimulation (TILS); Near-infrared spectroscopy (NIRS)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Short-term Memory Scores

  8 weeks

• Prefrontal Activations in Short-term Memory Processing

  8 weeks

Study Arms (2)

One TILS, one sham, and then five TILS interventions

EXPERIMENTAL

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

Device: TILS; Device: sham

One sham, then six TILS interventions

EXPERIMENTAL

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

Device: TILS; Device: sham

Interventions

TILS 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.

Also known as: Low-level laser therapy (LLLT)

One TILS, one sham, and then five TILS interventions; One sham, then six TILS interventions

sham 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 TILS, one sham, and then five TILS interventions; One sham, then six TILS interventions

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas at Arlington: lead
• University of Texas at Austin: collaborator

Study Sites (1)

Engineering Research Building (ERB), University of Texas Arlington

Arlington, Texas, 76010, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Results Point of Contact

• Title: Fenghua Tian
• Organization: University of Texas at Arlington

fenghua.tian@gmail.com

8178075271

Study Officials

• Fenghua Tian, PhD

  University of Texas at Arlington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Research

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 6, 2017
• Study Start: October 1, 2017
• Primary Completion: October 8, 2019
• Study Completion: October 8, 2019
• Last Updated: July 23, 2021
• Results First Posted: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)