Stress ReactionNCT05298956
Brain Substrates for Cardiovascular Stress Physiology
A study testing Low-level laser therapy (LLLT) in people with Stress Reaction, run by Baylor University at 1 site in United States.
Trial summary
Transcranial infrared laser stimulation is a non-invasive neuromodulation technique. The study will examine the effect of transcranial infrared laser stimulation on cardiovascular and metabolic responses to stress. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Reaction
- What is being tested?
- Low-level laser therapy (LLLT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2022to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-30 years old
Who cannot join
- History of a diagnosed chronic medical or neurological disorder Current pregnancy Current illness or infection (e.g., cold, flu) Any condition that would prohibit them from engaging in physical exercise
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Annie T. Ginty
Waco, Texas, 76798
Annie T. Ginty, PhD, 254-710-2236, annie_ginty@baylor.edu
About this study
Transcranial infrared laser stimulation is a non-invasive neuromodulation technique. The study will examine the effect of transcranial infrared laser stimulation on cardiovascular and metabolic responses to stress.
Read the detailed description
Physiological responses to stress may be a potential pathway by which psychological stress relates to cardiovascular disease. Disproportionate (metabolically exaggerated) stressor-evoked cardiovascular reactions may accelerate atherosclerosis or influence risk of greater cardiovascular disease endpoints. The aim of this project is to use an experimental approach to examine if neuromodulation (transcranial infrared laser stimulation) alters stressor-evoked metabolic and cardiovascular responses.
- Conditions
- Stress Reaction
- Being tested
- Low-level laser therapy (LLLT)
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapy (LLLT)Other
Sham Comparator: Participants will receive 8 counts of 60 seconds of the same laser to the right forehead, however the laser power will be turned off and will be 0 Watts.
Transcranial infrared laser stimulation: Participants will receive 8 counts of 60 seconds of transcranial infrared laser stimulation to the right forehead. The wavelength will be 1064 nm and the laser power will be 3.4 Watts.
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Participants will receive sham laser to the right forehead. Receives: Other: Low-level laser therapy (LLLT) |
| Transcranial infrared laser stimulation | Active comparator | Participants will receive transcranial infrared laser stimulation to the right forehead. Receives: Other: Low-level laser therapy (LLLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption in response to acute psychological stress
This measurement takes into account oxygen consumption at baseline and during the stress task.
Measured: Immediately following intervention (up to 60 minutes)
Heart rate in response to acute psychological stress
This measurement takes into account heart rate at baseline and during the stress task.
Measured: Immediately following intervention (up to 60 minutes)
Additional heart rate in response to acute psychological stress
This measurement takes into account additional heart rate at baseline and during stress.
Measured: Immediately following intervention (up to 60 minutes)
Secondary outcomes (1)
Perceived stress
Ratings of perceived stressfulness (1 = not at all stressful, 7 = very stressful) of the acute psychological stress task
Measured: Immediately following intervention (up to 60 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start14 Mar 2022
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ReactionStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annie Ginty, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298956
- Sponsor's protocol ID
- 1437574
- Status last verified
- Jul 2023
- First submitted
- 21 Feb 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Substrates for Cardiovascular Stress Physiology
- ClinicalTrials.gov ID
- NCT05298956
- Acronym / sponsor ID
- 1437574
- Conditions
- Stress Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transcranial infrared laser stimulation is a non-invasive neuromodulation technique. The study will examine the effect of transcranial infrared laser stimulation on cardiovascular and metabolic responses to stress.
Detailed description
Physiological responses to stress may be a potential pathway by which psychological stress relates to cardiovascular disease. Disproportionate (metabolically exaggerated) stressor-evoked cardiovascular reactions may accelerate atherosclerosis or influence risk of greater cardiovascular disease endpoints. The aim of this project is to use an experimental approach to examine if neuromodulation (transcranial infrared laser stimulation) alters stressor-evoked metabolic and cardiovascular responses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Other: Low-level laser therapy (LLLT)Participants will receive sham laser to the right forehead. |
| Transcranial infrared laser stimulation | Active comparator | Other: Low-level laser therapy (LLLT)Participants will receive transcranial infrared laser stimulation to the right forehead. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-30 years old
Key exclusion criteria (1 listed)
- History of a diagnosed chronic medical or neurological disorder Current pregnancy Current illness or infection (e.g., cold, flu) Any condition that would prohibit them from engaging in physical exercise
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 |
|---|---|---|
| Low-level laser therapy (LLLT)Sham Comparator: Participants will receive 8 counts of 60 seconds of the same laser to the right forehead, however the laser power will be turned off and will be 0 Watts. Transcranial infrared laser stimulation: Participants will receive 8 counts of 60 seconds of transcranial infrared laser stimulation to the right forehead. The wavelength will be 1064 nm and the laser power will be 3.4 Watts. | Other | Sham, Transcranial infrared laser stimulation |
Primary outcome
Oxygen consumption in response to acute psychological stress
Time frame: Immediately following intervention (up to 60 minutes)
This measurement takes into account oxygen consumption at baseline and during the stress task.
Heart rate in response to acute psychological stress
Time frame: Immediately following intervention (up to 60 minutes)
This measurement takes into account heart rate at baseline and during the stress task.
Additional heart rate in response to acute psychological stress
Time frame: Immediately following intervention (up to 60 minutes)
This measurement takes into account additional heart rate at baseline and during stress.
1 secondary outcome
Perceived stress
Time frame: Immediately following intervention (up to 60 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level laser therapy (LLLT) in people with Stress Reaction, run by Baylor University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen consumption in response to acute psychological stress (time frame: Immediately following intervention (up to 60 minutes)). The study lists 3 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 1 Aug 2023; AzTrials last refreshed its copy on 31 Oct 2026.