- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03302130
The Effects of Mood on Cerebral Perfusion
November 8, 2022 updated by: University Ghent
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 Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy university students
- between 18 and 30 years old
Exclusion Criteria:
- No informed consent
- Not using hormonal contraception
- MRI-contraindications
- Claustrophobia
- Pregnancy
- Chronic diseases and chronic medication use
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Imaging healthy volunteers
Mood induction: positive, negative, neutral mood (using subjects own memories) Arterial spin labeling MRI Physiological monitoring
|
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
Single PLD PCASL
During MRI: heart rate, end-tidal CO2, respiratory rate and skin conductance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 minutes (ASL scan during mood state induction)
|
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.
|
2 minutes (ASL scan during mood state induction)
|
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.
|
2 minutes (ASL scan during mood state induction)
|
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.
|
2 minutes (ASL scan after mood state induction)
|
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.
|
2 minutes (ASL scan after mood state induction)
|
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.
|
2 minutes (ASL scan after mood state induction)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 8, 2016
Primary Completion (ACTUAL)
October 30, 2017
Study Completion (ACTUAL)
November 17, 2017
Study Registration Dates
First Submitted
October 6, 2016
First Submitted That Met QC Criteria
September 29, 2017
First Posted (ACTUAL)
October 4, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 14, 2022
Last Update Submitted That Met QC Criteria
November 8, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- EC/2015/0528
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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