Brain Substrates for Cardiovascular Stress Physiology

July 28, 2023 updated by: Annie Ginty, Baylor University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

18-30 years old

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham
Participants will receive sham laser to the right forehead.
Other: 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.
Active Comparator: Transcranial infrared laser stimulation
Participants will receive transcranial infrared laser stimulation to the right forehead.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately following intervention (up to 60 minutes)
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.
Immediately following intervention (up to 60 minutes)
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.
Immediately following intervention (up to 60 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived stress
Time Frame: Immediately following intervention (up to 60 minutes)
Ratings of perceived stressfulness (1 = not at all stressful, 7 = very stressful) of the acute psychological stress task
Immediately following intervention (up to 60 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

February 21, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1437574

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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