Cerebral PerfusionNCT03302130
The Effects of Mood on Cerebral Perfusion
A study testing Mood induction (using own memories), Arterial spin labeling MRI and Physiological monitoring in people with Cerebral Perfusion, run by University Ghent.
Trial summary
Measuring brain perfusion is biased by a inter- and intrasubject variability, caused by physiological and lifestyle factors. In this study, the investigators want to investigate the effects of a different mood state (neutral, positive and negative mood), induced using subjects own memories, on both global and regional… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Perfusion
- What is being tested?
- Mood induction (using own memories), Arterial spin labeling MRI and Physiological monitoring
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2016to 17 Nov 2017
- Phase
- Interventional
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy university students
- between 18 and 30 years old
Who cannot join
- No informed consent
- Not using hormonal contraception
- MRI-contraindications
- Claustrophobia
- Pregnancy
- Chronic diseases and chronic medication use
About this study
Measuring brain perfusion is biased by a inter- and intrasubject variability, caused by physiological and lifestyle factors. In this study, the investigators want to investigate the effects of a different mood state (neutral, positive and negative mood), induced using subjects own memories, on both global and regional cerebral perfusion, measured with arterial spin labeling.
- Conditions
- Cerebral Perfusion
- Being tested
- Mood induction (using own memories), Arterial spin labeling MRI, Physiological monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mood induction (using own memories)Behavioural
Subjects deliver three positive, three negative and three neutral memories 30 seconds reliving a memory - answering questions about the memory - reliving memory for 2 minutes during ASL-MRI
Arterial spin labeling MRIDevice
Single PLD PCASL
Physiological monitoringDevice
During MRI: heart rate, end-tidal CO2, respiratory rate and skin conductance
| Study group | Role | What they receive |
|---|---|---|
| Imaging healthy volunteers | Experimental | Mood induction: positive, negative, neutral mood (using subjects own memories) Arterial spin labeling MRI Physiological monitoring Receives: Behavioral: Mood induction (using own memories); Device: Arterial spin labeling MRI; Device: Physiological monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Cerebral perfusion (ml/100g/min) during positive mood induction
Effect of positive mood induction (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
Measured: 2 minutes (ASL scan during mood state induction)
Regional Cerebral perfusion (ml/100g/min) during negative mood induction
Effect of negative mood induction (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
Measured: 2 minutes (ASL scan during mood state induction)
Regional Cerebral perfusion (ml/100g/min) during neutral mood induction
Effect of neutral mood induction (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
Measured: 2 minutes (ASL scan during mood state induction)
Regional Cerebral perfusion (ml/100g/min) after positive mood induction
Effect of positive mood (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
Measured: 2 minutes (ASL scan after mood state induction)
Regional Cerebral perfusion (ml/100g/min) after negative mood induction
Effect of negative mood (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
Measured: 2 minutes (ASL scan after mood state induction)
Regional Cerebral perfusion (ml/100g/min) after neutral mood induction
Effect of neutral mood (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
Measured: 2 minutes (ASL scan after mood state induction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start8 Jan 2016
- Primary completion30 Oct 2017
- Study completion17 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PerfusionStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Achten, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302130
- Sponsor's protocol ID
- EC/2015/0528
- Status last verified
- Nov 2022
- First submitted
- 6 Oct 2016
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mood on Cerebral Perfusion
- ClinicalTrials.gov ID
- NCT03302130
- Acronym / sponsor ID
- EC/2015/0528
- Conditions
- Cerebral Perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 8 Jan 2016 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 17 Nov 2017 (actual)
- First posted
- 4 Oct 2017 (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.
Measuring brain perfusion is biased by a inter- and intrasubject variability, caused by physiological and lifestyle factors. In this study, the investigators want to investigate the effects of a different mood state (neutral, positive and negative mood), induced using subjects own memories, on both global and regional cerebral perfusion, measured with arterial spin labeling.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging healthy volunteers | Experimental | Behavioral: Mood induction (using own memories), Device: Arterial spin labeling MRI, Device: Physiological monitoringMood induction: positive, negative, neutral mood (using subjects own memories) Arterial spin labeling MRI Physiological monitoring |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy university students
- between 18 and 30 years old
Key exclusion criteria (6 listed)
- No informed consent
- Not using hormonal contraception
- MRI-contraindications
- Claustrophobia
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mood induction (using own memories)Subjects deliver three positive, three negative and three neutral memories 30 seconds reliving a memory - answering questions about the memory - reliving memory for 2 minutes during ASL-MRI | Behavioural | Imaging healthy volunteers |
| Arterial spin labeling MRISingle PLD PCASL | Device | Imaging healthy volunteers |
| Physiological monitoringDuring MRI: heart rate, end-tidal CO2, respiratory rate and skin conductance | Device | Imaging healthy volunteers |
Primary outcome
Regional Cerebral perfusion (ml/100g/min) during positive mood induction
Time frame: 2 minutes (ASL scan during mood state induction)
Effect of positive mood induction (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
Regional Cerebral perfusion (ml/100g/min) during negative mood induction
Time frame: 2 minutes (ASL scan during mood state induction)
Effect of negative mood induction (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
Regional Cerebral perfusion (ml/100g/min) during neutral mood induction
Time frame: 2 minutes (ASL scan during mood state induction)
Effect of neutral mood induction (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
Regional Cerebral perfusion (ml/100g/min) after positive mood induction
Time frame: 2 minutes (ASL scan after mood state induction)
Effect of positive mood (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
Regional Cerebral perfusion (ml/100g/min) after negative mood induction
Time frame: 2 minutes (ASL scan after mood state induction)
Effect of negative mood (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
Regional Cerebral perfusion (ml/100g/min) after neutral mood induction
Time frame: 2 minutes (ASL scan after mood state induction)
Effect of neutral mood (using volunteer's own memories) on cerebral perfusion using arterial spin labeling MRI.
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 14 Nov 2022.
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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.
Eric Achten, MD, PhD principal investigator
University Hospital, Ghent
Questions about this trial
What is this clinical trial studying?
A study testing Mood induction (using own memories), Arterial spin labeling MRI and Physiological monitoring in people with Cerebral Perfusion, run by University Ghent.
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 2 inclusion and 6 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 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Regional Cerebral perfusion (ml/100g/min) during positive mood induction (time frame: 2 minutes (ASL scan during mood state induction)). The study lists 6 primary outcomes in all. 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 14 Nov 2022.