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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Other: Functional Magnetic Resonance Imaging (fMRI)

• Registration Number: NCT04464265
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-09
• Study Start: 2021-04-19
• Primary Completion: 2022-08-05
• Study Completion: 2022-08-05
• Status Verified: 2023-08
• Results First Submitted: 2023-08-03
• Results First Submitted QC: 2023-08-29
• Last Update Submitted: 2023-08-29
• Results First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Functional Magnetic Resonance Imaging	Functional Magnetic Resonance Imaging (fMRI)	While music is played Noninvasive functional magnetic resonance (fMRI) imaging will be performed at the University of Michigan Health System, University Hospital, Department of Radiology. The fMRI is done under anesthesia using propofol. The researchers will manually control the infusion of propofol to achieve target effect-site concentrations of 1.2, 1.6, 2.0, and 2.4 μg/ml in a stepwise fashion.

Primary Outcome Measures

Name	Time	Method
Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation	60 minutes	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).

Secondary Outcome Measures

Name	Time	Method
Average Squeeze Pressure Over 60 Minutes	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).

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States