Post-traumatic Stress Disorder (PTSD)NCT03209882
Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Cognition in Post-traumatic Stress Disorder (PTSD)
A study testing TILS in people with Post-traumatic Stress Disorder (PTSD), run by The University of Texas at Arlington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-traumatic Stress Disorder (PTSD)
- What is being tested?
- TILS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 8 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Engineering Research Building (ERB), University of Texas Arlington
Arlington, Texas, 76010
About this study
Official title: Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Metabolism and Function in Post-traumatic Stress Disorder (PTSD)
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.
Read the 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)
- Being tested
- TILS, sham
- Keywords
- Transcranial infrared laser stimulation (TILS), Near-infrared spectroscopy (NIRS)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TILSDevice
Also called Low-level laser therapy (LLLT)
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.
shamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TILS; Device: sham |
| One sham, then six TILS interventions | Experimental | Participants first received a sham session, followed by six weekly TILS sessions. Receives: Device: TILS; Device: sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral CCO Changes in Response to TILS and Sham
Cerebral CCO changes measured by broadband NIRS during six TILS interventions and one sham session.
Measured: 7 weeks
Cerebral Hemodynamic Changes in Response to TILS and Sham
Cerebral hemodynamic changes measured by broadband NIRS during every TILS or sham session
Measured: 7 weeks
Secondary outcomes (2)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start1 Oct 2017
- Primary completion8 Oct 2019
- Study completion8 Oct 2019
Why it stopped: IRB approval terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Arlington
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin
- Responsible party
- Principal investigator, Fenghua Tian, PhD, The University of Texas at Arlington
- Investigators
- Fenghua Tian, PhD, Principal investigator, University of Texas at Arlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209882
- Sponsor's protocol ID
- 2017-0512
- Status last verified
- Jun 2021
- First submitted
- 30 Jun 2017
- Last updated
- 23 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Metabolism and Function in Post-traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT03209882
- Acronym / sponsor ID
- 2017-0512
- Conditions
- Post-traumatic Stress Disorder (PTSD)
- Keywords
- Transcranial infrared laser stimulation (TILS), Near-infrared spectroscopy (NIRS)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB approval terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The University of Texas at ArlingtonUniversity, hospital or other
- Collaborators
- University of Texas at Austin
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 8 Oct 2019 (actual)
- Study completion
- 8 Oct 2019 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Posted 14 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One TILS, one sham, and then five TILS interventions | Experimental | Device: TILS, Device: shamParticipants first received a TILS intervention, followed by a sham session one week later. Then, participants received another five weekly TILS interventions. |
| One sham, then six TILS interventions | Experimental | Device: TILS, Device: shamParticipants first received a sham session, followed by six weekly TILS sessions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TILSAlso: Low-level laser therapy (LLLT)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. | Device | One TILS, one sham, and then five TILS interventions, One sham, then six TILS interventions |
| shamThe 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. | Device | One TILS, one sham, and then five TILS interventions, One sham, then six TILS interventions |
Primary outcome
Cerebral CCO Changes in Response to TILS and Sham
Time frame: 7 weeks
Cerebral CCO changes measured by broadband NIRS during six TILS interventions and one sham session.
Cerebral Hemodynamic Changes in Response to TILS and Sham
Time frame: 7 weeks
Cerebral hemodynamic changes measured by broadband NIRS during every TILS or sham session
2 secondary outcomes
Short-term Memory Scores
Time frame: 8 weeks
Prefrontal Activations in Short-term Memory Processing
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Post-traumatic Stress Disorder (PTSD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fenghua Tian, PhD principal investigator
University of Texas at Arlington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TILS in people with Post-traumatic Stress Disorder (PTSD), run by The University of Texas at Arlington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral CCO Changes in Response to TILS and Sham (time frame: 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.