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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05298956
Other study ID # 1437574
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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