NCT03302130

Brief 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 cerebral perfusion, measured with arterial spin labeling.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
12 months until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2017

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

1.8 years

First QC Date

October 6, 2016

Last Update Submit

November 8, 2022

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    2 minutes (ASL scan after mood state induction)

Study Arms (1)

Imaging healthy volunteers

EXPERIMENTAL

Mood induction: positive, negative, neutral mood (using subjects own memories) Arterial spin labeling MRI Physiological monitoring

Behavioral: Mood induction (using own memories)Device: Arterial spin labeling MRIDevice: Physiological monitoring

Interventions

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

Imaging healthy volunteers

Single PLD PCASL

Imaging healthy volunteers

During MRI: heart rate, end-tidal CO2, respiratory rate and skin conductance

Imaging healthy volunteers

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy university students
  • between 18 and 30 years old

You may not qualify if:

  • No informed consent
  • Not using hormonal contraception
  • MRI-contraindications
  • Claustrophobia
  • Pregnancy
  • Chronic diseases and chronic medication use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Monitoring, Physiologic

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Eric Achten, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 4, 2017

Study Start

January 8, 2016

Primary Completion

October 30, 2017

Study Completion

November 17, 2017

Last Updated

November 14, 2022

Record last verified: 2022-11