Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay
MANCAVA sets out fundamental methodologies for characterizing human fundamental physiological system interactions at a whole-body level, particularly focusing on the interplay among cortical brain activity, autonomic function, and cerebrovascular autoregulatory mechanisms. By investigating the complex, time-varying mechanisms underlying the multisystem dynamic interactions, novel methods linking various brain areas and reflex functions to target organs and districts such as heart and circulatory system are proposed with the clinical aim linked to the emerging topic of depression.
In this scenario, proper new mathematical tools will allow a significant leap from the current state of the art, paving the way towards a new understanding of leading comorbid contributors to global diseases such as cardiac and cerebrovascular morbidity in mood disorders. In turn, this will provide an integration among physiological and psychological dimensions for a more holistic view on depression.
Researchers, professionals, and patients will all benefit from a comprehensive assessment of brain-mind-body interplay, leading to the new extended definition of default mode/mood network, neurovascular-evoked responses to autonomic stimuli, brain-autonomic consequences of emotional responses, and physiological substrates of depressive states.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Milan
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San Donato Milanese, Milan, Italy, 20097
- Recruiting
- IRCCS Policlinico San Donato
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Sub-Investigator:
- Vlasta Bari, PhD
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Principal Investigator:
- Marco Ranucci, MD
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Sub-Investigator:
- Alberto Porta, PhD
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Contact:
- Vlasta Bari, PhD
- Phone Number: +390252774381
- Email: vlasta.bari@grupposandonato.it
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Sub-Investigator:
- Beatrice Cairo, PhD
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Contact:
- Pavandeep Singh
- Email: pavandeep.singh@grupposandonato.it
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Sub-Investigator:
- Francesca Gelpi, Ms
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age older than 18 years
- spontaneous sinus rhythm
- signed informed consent
- indication to heart surgery
Exclusion Criteria:
- age lower than 18 years
- absence of sinus rhythm
- pregnancy
- impossibility of informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Cardiac surgery
An experimental setup will be devised for the simultaneous monitoring and recording of EEG, ECG, AP, and R together with CBF in patients scheduled for major cardiac surgery.
Recording sessions will take place 1 day before (PRE) and within 7 days after (POST) surgery.
The experimental protocol including physiological data recordings includes three sessions lasting 10 minutes each: a session at resting state in supine position, a session during autonomic challenge obtained via active standing evoking reflex sympathetic activation, and a session of emotional elicitation via the administration of videos.
The overall duration of the experiment is therefore 30 minutes in PRE and POST.
A total of 40 short video clips of the duration of 15 seconds each will be presented to a total of 80 voluteers will be recruited for the MANCAVA study.
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From a clinical perspective, MANCAVA will especially target neuro-cardiovascular health and mood disorders such as depression
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Autoregulation index (ARI)
Time Frame: 24 months
|
ARI is an index describing the state of cerebral autoregulation from mean cerebral blood velocity and mean arterial pressure.
It ranges between 1 and 9. ARI>4 means working autoregulation.
ARI<4 means impaired autoregulation.
It will be computed for all participants in PRE and POST.
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24 months
|
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number of patients developing depression
Time Frame: 24 months
|
The number of patients developing depression will be assessed by the results of psychometric tests
|
24 months
|
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Baroreflex sensitivity
Time Frame: 24 months
|
Baroreflex sensitivity will be measured in ms/mmHg.
A higher value means a better baroreflex regulation.
It will be computed in all participants in PRE and POST surgery.
|
24 months
|
|
Cortical activity
Time Frame: 24 months
|
Power of EEG in Alpha and Beta band will be measured in square microvolt
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MANCAVA
- 2022SLB5MX (Other Grant/Funding Number: Italian Ministry of Research)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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