Brain Substrates for Cardiovascular Stress Physiology

Stress Reaction Clinical Trial

Official title:

Brain Substrates for Cardiovascular Stress Physiology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05298956
• Other study ID #: 1437574
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Baylor University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Stress
• Stress Reaction

Intervention

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.

Locations

Country	Name	City	State
United States	Annie T. Ginty	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen consumption in response to acute psychological stress	This measurement takes into account oxygen consumption at baseline and during the stress task.	Immediately following intervention (up to 60 minutes)
Primary	Heart rate in response to acute psychological stress	This measurement takes into account heart rate at baseline and during the stress task.	Immediately following intervention (up to 60 minutes)
Primary	Additional heart rate in response to acute psychological stress	This measurement takes into account additional heart rate at baseline and during stress.	Immediately following intervention (up to 60 minutes)
Secondary	Perceived stress	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)