Back to resultsBrain Substrates for Cardiovascular Stress Physiology
Primary Purpose
Stress Reaction
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-level laser therapy (LLLT)
Sponsored by
About this trial
This is an interventional basic science trial for Stress Reaction
Eligibility Criteria
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
Sites / Locations
- Annie T. GintyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Sham
Transcranial infrared laser stimulation
Arm Description
Participants will receive sham laser to the right forehead.
Participants will receive transcranial infrared laser stimulation to the right forehead.
Outcomes
Primary Outcome Measures
Oxygen consumption in response to acute psychological stress
This measurement takes into account oxygen consumption at baseline and during the stress task.
Heart rate in response to acute psychological stress
This measurement takes into account heart rate at baseline and during the stress task.
Additional heart rate in response to acute psychological stress
This measurement takes into account additional heart rate at baseline and during stress.
Secondary Outcome Measures
Perceived stress
Ratings of perceived stressfulness (1 = not at all stressful, 7 = very stressful) of the acute psychological stress task
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05298956
Brief Title
Brain Substrates for Cardiovascular Stress Physiology
Official Title
Brain Substrates for Cardiovascular Stress Physiology
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Reaction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Participants will receive sham laser to the right forehead.
Arm Title
Transcranial infrared laser stimulation
Arm Type
Active Comparator
Arm Description
Participants will receive transcranial infrared laser stimulation to the right forehead.
Intervention Type
Other
Intervention Name(s)
Low-level laser therapy (LLLT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oxygen consumption in response to acute psychological stress
Description
This measurement takes into account oxygen consumption at baseline and during the stress task.
Time Frame
Immediately following intervention (up to 60 minutes)
Title
Heart rate in response to acute psychological stress
Description
This measurement takes into account heart rate at baseline and during the stress task.
Time Frame
Immediately following intervention (up to 60 minutes)
Title
Additional heart rate in response to acute psychological stress
Description
This measurement takes into account additional heart rate at baseline and during stress.
Time Frame
Immediately following intervention (up to 60 minutes)
Secondary Outcome Measure Information:
Title
Perceived stress
Description
Ratings of perceived stressfulness (1 = not at all stressful, 7 = very stressful) of the acute psychological stress task
Time Frame
Immediately following intervention (up to 60 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Annie T. Ginty
City
Waco
State/Province
Texas
ZIP/Postal Code
76798
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie T. Ginty, PhD
Phone
254-710-2236
Email
annie_ginty@baylor.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Brain Substrates for Cardiovascular Stress Physiology
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