Reproducibility of Brain MRI — DANA0  

Reproducibility of Results Clinical Trial

Official title: Danish Anaesthesia Study (DANA) 0: Reproducibility of Structural and Functional Magnetic Resonance Imaging of the Brain in Healthy Volunteers - a Pilot Study. First Substudy of the Protocol, 'Neuroplasticity Induced by General Anaesthesia'

Status Completed

Clinical Trial Summary

The aim of this study is to assess the reproducibility over time of functional and structural magnetic resonance imaging, as well as specific biomarkers in plasma in healthy volunteers before and after a two-hour rest. This design mimics the timing of repeated scans and blood sampling before and after two hours of anaesthesia in subsequent substudies of the protocol, 'Neuroplasticity Induced by General Anaesthesia'.

Clinical Trial Description

In the study 'Neuroplasticity Induced by General Anaesthesia', the investigators intend to explore the effects of general anaesthesia on the brain by state-of-the-art magnetic resonance imaging (MRI).

MRI data - especially changes in functional MRI recordings - may theoretically depend on a variety of physiological variables such as cerebral blood flow, cerebral blood volume, and cerebral metabolic oxidative rate of oxygen, and may thus also be affected by pharmacological agents. However, to interpret data it is important to know the inherent variability of the scans.

This first substudy therefore aims to determine the reproducibility of the MRI recordings without administration of pharmacological agents. Another aim of the study is to ensure feasibility of the design before embarking on the more resource-demanding substudies in anaesthetised subjects.

In this substudy, the investigators will perform the same MRI measurements as in the main study; rather than undergoing two hours of general anaesthesia, the volunteers will be subjected to two hours of undisturbed rest.

Each participant goes through a pre-study interview and physical examination to ensure that the participant is healthy and suitable for participation.

For each participant, the study consists of three study days:

Day 0: Baseline MRI and blood tests. Intervention. Two hours of post-intervention care followed by post-intervention MRI and blood tests.

Day +1 (the day after Day 0): MRI and blood tests. Day +7 (one week after Day 0): MRI and blood tests.

All MRI scans will be performed with a 3 Tesla Philips Achieva d-stream with a 32-channel receive head coil.

Blood tests: Haemoglobin, sodium, potassium, white blood count, C-reactive protein (CRP), S calcium-binding protein 100b (S100b), neuron-specific enolase (NSE), interleukin-1 (IL-1), IL-6, IL-8, IL-10, IL-18, tumor necrosis factor Alpha (TNF-Alpha) and transforming growth factor beta (TGF-beta). ;

Related Conditions & MeSH terms

• Reproducibility of Results

• NCT number: NCT03876236
• Study type: Observational
• Source: Rigshospitalet, Denmark
• Status: Completed
• Start date: February 4, 2019
• Completion date: May 4, 2019