Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay

Depression Clinical Trial

Official title:

Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06294119
• Other study ID #: MANCAVA
• Secondary ID: 2022SLB5MX
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2024
• Est. completion date: February 8, 2026

Study information

• Verified date: February 2024
• Source: IRCCS Policlinico S. Donato
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 8, 2026
• Est. primary completion date: February 8, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Depression
• Heart Diseases

Intervention

Procedure:
• Major Cardiac surgery
From a clinical perspective, MANCAVA will especially target neuro-cardiovascular health and mood disorders such as depression

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Donato	San Donato Milanese	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autoregulation index (ARI)	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.	24 months
Primary	number of patients developing depression	The number of patients developing depression will be assessed by the results of psychometric tests	24 months
Primary	Baroreflex sensitivity	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
Primary	Cortical activity	Power of EEG in Alpha and Beta band will be measured in square microvolt	24 months