Ignite Creation Date:
2024-05-06 @ 2:01 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04199143
Status:
COMPLETED
Last Update Posted:
2021-06-29
First Post:
2019-12-05
Brief Title:
Brain Reactivity to Nitrous Oxyde in Depression an MRI and Ultrasound Study PROTOBRAIN Pilote
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
Cerebrovascular Reactivity to Nitrous Oxyde in Resistant Depression the PROTOBRAIN Pilote Study
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recent evidence suggest that Nitrous Oxyde N2O could exhibit antidepressant effect in treatment-resistant depression TRD However the pathophysiology of this effect remains unclear and could include glutamatergic activity but also cerebrovascular effects and changes in brain connectivity The goal of our study is to characterize brain reactivity to N2O in TRD patients as assessed with Ultrasound Tissue Pulsatility Imaging TPI and Magnetic Resonance Imaging MRI including Arterial Spin Labeling - ASL - for brain perfusion and Blood-Oxygen-Level Dependent - BOLD - for brain connectivity and pulsatility
Ultrasound and MRI Neuroimaging will be measured before during and after a single one-hour exposure of a 50N2050O2 mixture in depressed individuals n20 and healthy volunteers n10 We make the hypothesis that brain reactivity will be lower in depressed individuals nonresponders to N2O compared to responders and healthy controls This study would provide further characterisation of the pathophysiology of the antidepressant response to N2O as well as providing potential biomakers Ultrasound and MRI for treatment response to N2O in TRD
Ultrasound and MRI Neuroimaging will be measured before during and after a single one-hour exposure of a 50N2050O2 mixture in depressed individuals n20 and healthy volunteers n10 We make the hypothesis that brain reactivity will be lower in depressed individuals nonresponders to N2O compared to responders and healthy controls This study would provide further characterisation of the pathophysiology of the antidepressant response to N2O as well as providing potential biomakers Ultrasound and MRI for treatment response to N2O in TRD
Detailed Description:
Neuroimaging examinations will include
Ultrasound Tissue Pulsatility Imaging for assessment of Brain Tissue Pulsatility BTP which reflects reactivity in brain movements and mechanical brain properties
MRI with structural and functional assessments namely brain volumes white matter lesions ASL for brain perfusion and BOLD for resting-state connectivity and brain pulsatility
MRI will be performed before and after a single one-hour exposure of 50N2O50O2 mixture Ultrasound will be performed before after and also during gas exposure Changes in these neuroimaging parameters will constitute the primary assessment of the study Psychometric and safety assessements will complete the neuroimaging outcomes
Follow-up will includes 1 a baseline visit for baseline MRI and Psychometric assessements 2 a second visit for gas exposure and neuroimaging assessements 3 a third and fourth visits for psychometric and safety assessements respectively 24 hours and one week after gas exposure
Ultrasound Tissue Pulsatility Imaging for assessment of Brain Tissue Pulsatility BTP which reflects reactivity in brain movements and mechanical brain properties
MRI with structural and functional assessments namely brain volumes white matter lesions ASL for brain perfusion and BOLD for resting-state connectivity and brain pulsatility
MRI will be performed before and after a single one-hour exposure of 50N2O50O2 mixture Ultrasound will be performed before after and also during gas exposure Changes in these neuroimaging parameters will constitute the primary assessment of the study Psychometric and safety assessements will complete the neuroimaging outcomes
Follow-up will includes 1 a baseline visit for baseline MRI and Psychometric assessements 2 a second visit for gas exposure and neuroimaging assessements 3 a third and fourth visits for psychometric and safety assessements respectively 24 hours and one week after gas exposure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None