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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03209882
Other study ID # 2017-0512
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date October 8, 2019

Study information

Verified date June 2021
Source The University of Texas at Arlington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date October 8, 2019
Est. primary completion date October 8, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Engineering Research Building (ERB), University of Texas Arlington Arlington Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas at Arlington University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
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