Reproducibility of ResultsDANA0NCT03876236
Reproducibility of Brain MRI
An observational study of Reproducibility of Results, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Reproducibility of Results
- How many people
- 10 participants
- Where
- 2 sitesDenmark
- Study dates
- 4 Feb 2019to 4 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy young volunteers
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
Show all 33Show fewer
- 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
- Declines receiving information regarding incidental pathological findings during MRI scans of the brain.
- Otherwise judged unfit for participation by the investigator
- Major trauma or head trauma with any symptoms present at the time of inclusion
- Surgery less than six weeks prior to the study period
- Infection (with fever) less than two weeks prior to the study period
- Expected or suspected difficult airway
- History of complications to general anaesthesia
- Known incident of malignant hyperthermia or unexplained complications to general anaesthesia among close relatives.
- Exclusion criteria during the study (leading to withdrawal):
- Any of the above-mentioned exclusion criteria
- Consumption of more than 3 units of alcohol within 24 hours before each study day (intervention day or MRI scan day)
- Consumed analgesics within 3 days before each study day
- Consumed anti-histamines less than 48 hours before each study day
- Intake of caffeine 12 h prior to each study day
- Smoking
- Major trauma or head trauma during the study period
- Surgery less during the study period
- Fever due to any infection < 14 days before the study or during the study
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Neuroanaesthesiology
Glostrup Municipality, Capital Region, 2600
Functional Imaging Unit, Department for Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Glostrup
Glostrup Municipality, Capital Region, 2600
About this study
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'
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'.
Read the detailed 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).
- Conditions
- Reproducibility of Results
- Keywords
- Magnetic Resonance Imaging, Diffusion Tensor Imaging, Reproducibility of Results, Feasibility Study, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rest | Quiet rest in supine position, 2 hrs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start4 Feb 2019
- Primary completion4 May 2019
- Study completion4 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproducibility of ResultsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirsten Moller, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kirsten Moller, MD PhD MDSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876236
- Sponsor's protocol ID
- H-18020364
- Acronym
- DANA0
- Status last verified
- Mar 2021
- First submitted
- 8 Feb 2019
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The responsible investigators will consider data sharing, considered compliance with GDPR regulations and data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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'
- ClinicalTrials.gov ID
- NCT03876236
- Acronym / sponsor ID
- DANA0 / H-18020364
- Conditions
- Reproducibility of Results
- Keywords
- Magnetic Resonance Imaging, Diffusion Tensor Imaging, Reproducibility of Results, Feasibility Study, Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 4 May 2019 (actual)
- Study completion
- 4 May 2019 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rest | – | –Quiet rest in supine position, 2 hrs. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy young volunteers
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility and reproducibility: rates of protocol violation and delays as well as adverse events
Time frame: 8 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: No. The responsible investigators will consider data sharing, considered compliance with GDPR regulations and data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Moller, MD PhD MDSc principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reproducibility of Results, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and reproducibility: rates of protocol violation and delays as well as adverse events (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.