Brain Substrates for Cardiovascular Stress Physiology
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2022
CompletedStudy Start
First participant enrolled
March 14, 2022
CompletedFirst Posted
Study publicly available on registry
March 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedAugust 1, 2023
July 1, 2023
2.4 years
February 21, 2022
July 28, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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)
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)
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 Outcomes (1)
Perceived stress
Immediately following intervention (up to 60 minutes)
Study Arms (2)
Sham
SHAM COMPARATORParticipants will receive sham laser to the right forehead.
Transcranial infrared laser stimulation
ACTIVE COMPARATORParticipants will receive transcranial infrared laser stimulation to the right forehead.
Interventions
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.
Eligibility Criteria
You may qualify if:
- years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Annie T. Ginty
Waco, Texas, 76798, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 21, 2022
First Posted
March 28, 2022
Study Start
March 14, 2022
Primary Completion
August 1, 2024
Study Completion
August 1, 2024
Last Updated
August 1, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share