Magnetic Resonance Imaging of the Effect of Music Listening on Brain Activity Under Anesthesia

Healthy Clinical Trial

Official title:

Magnetic Resonance Imaging of the Effect of Music Listening on Brain Activity Under Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04464265
• Other study ID #: HUM00176300
• Secondary ID: R01GM103894
• Status: Completed
• Phase: Phase 4
• Start date: April 19, 2021
• Est. completion date: August 5, 2022

Study information

• Verified date: August 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to better understand the systems-level neuronal mechanisms by which general anesthetics produce loss of consciousness.The researchers believe that anesthetics suppress consciousness by disrupting the functioning of large-scale brain networks that support information integration in the brain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 5, 2022
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologist physical status of 1 (ASA-1), Healthy, non-smoking, no or minimal alcohol use

• Right-handed

• Body mass index (BMI) of less than 30

• English speakers

Exclusion Criteria:

• Medical contraindication to Magnetic Resonance Imaging (MRI) scanning

• Unable to undergo MRI scanning because of possible pregnancy

• BMI over 30

• Tattoos in the head or neck region

• Unwilling to abstain from alcohol for 24 hours prior to dosing

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Functional Magnetic Resonance Imaging (fMRI)
Propofol will be administered by intravenous infusion. All anesthesia equipment, supplies, and drugs will be provided by anesthesiologists from the University of Michigan Health System. The researchers will manually control the infusion of propofol to achieve target effect-site concentrations which will be maintained for 4 minutes each. Four types of music, including Jazz, Rock, Pop and Country, will be presented in a pseudo-randomized order. During the behavioral test period, participants will be asked to squeeze an Magnetic Resonance Imaging (MRI) compatible grip dynamometer (a rubber ball) for every 10-second periods (96 cycles in total). The beginning of each cycle will be cued with the spoken word "squeeze".

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation	Music evoked activity was quantified by measurements of the fMRI BOLD signal. Neural response to a natural auditory stimulus, music, was assessed during both conscious and anesthetized states. Measurements were taken at baseline (30 minutes) and during anesthesia (60 minutes).	60 minutes
Secondary	Average Squeeze Pressure Over 60 Minutes	Measurement of force of participants' hand squeezing on a rubber ball in response to instructions. This will be measured in millimeters of mercury (mmHg) of air pressure during squeezing the rubber ball. Measurements are provided for the 30-minute means based on measurements taken every 10 seconds for 30 minutes prior to intervention (baseline) and every 10 seconds for 30 minutes during intervention (intervention), using BIOPAC (https://www.biopac.com) MP160 system with AcqKnowledge software (V5.0).	60 minutes