Reproducibility of Brain MRI

NCT03876236 | Completed DMC

• 1 other identifier: H-18020364
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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'.

Conditions

Reproducibility of Results

Keywords

Magnetic Resonance Imaging; Diffusion Tensor Imaging; Reproducibility of Results; Feasibility Study; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Feasibility and reproducibility: rates of protocol violation and delays as well as adverse events

  Evaluation of feasibility of study set-up, as measured by rates of protocol violation and delays as well as adverse events. The time frame mentioned below runs from the first study day, NOT from eligibility interview.

  8 days

Study Arms (1)

Rest

Quiet rest in supine position, 2 hrs.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy young volunteers

You may qualify if:

• Age ≥18 ≤35
• Healthy individual
• Normal electrocardiogram (ECG)
• Normal physical examination, including neurological examination, auscultation of the heart and lungs, and measurement of blood pressure and pulse.
• Speaks and understands Danish
• Provides oral and written informed consent
• Right-handed
• American Society of Anaesthesiologists (ASA) class 1 (2)
• Mallampati I-II and simplified airway risk index (SARI) 0-2 (i.e. no indication of difficult intubation. See Appendix for details)
• BMI ≥18 kg/m2 and ≤30kg/m2
• Female participants must use safe contraceptives.

You may not qualify if:

• Cannot cooperate to tests
• Left-handedness or ambidexterity
• History of cancer, immune disease, autoimmune disease, chronic pain, neurological / psychiatric illness or other serious illness
• Pregnancy
• Weakly intake of \>21 (males) or \>14 (females) units of alcohol
• Substance abuse (assessed by the investigator)
• Daily use of any medication (contraceptives allowed)
• Consumed anti-depressants during the last 30 days before study days
• Heavy intake of caffeine (\> 5 cups/day)
• Smoking during the last 30 days before study days
• Reflux or dyspepsia
• Poor dental status or oral health
• Contraindication to MRI
• Allergy to any kind of medication or material to which the volunteer could be exposed to during this study
• Family history of malignant hyperthermia

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (2)

Department of Neuroanaesthesiology

Glostrup Municipality, Capital Region, 2600, Denmark

Location

Functional Imaging Unit, Department for Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Glostrup

Glostrup Municipality, Capital Region, 2600, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

Study Officials

• Kirsten Moller, MD PhD MDSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, consultant, PhD, DMSc

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: March 15, 2019
• Study Start: February 4, 2019
• Primary Completion: May 4, 2019
• Study Completion: May 4, 2019
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)