NCT Number: NCT06294119
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
San Donato Milanese, Milan, 20097, Italy
Location status: Recruiting
Alberto Porta, PhD
SUB_INVESTIGATOR
Beatrice Cairo, PhD
SUB_INVESTIGATOR
Francesca Gelpi, Ms
SUB_INVESTIGATOR
Marco Ranucci, MD
PRINCIPAL_INVESTIGATOR
Pavandeep Singh
CONTACT
Vlasta Bari, PhD
CONTACT
Vlasta Bari, PhD
SUB_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
From a clinical perspective, MANCAVA will especially target neuro-cardiovascular health and mood disorders such as depression
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.
Time frame: 24 months
The number of patients developing depression will be assessed by the results of psychometric tests
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.
Time frame: 24 months
Power of EEG in Alpha and Beta band will be measured in square microvolt
IRCCS Policlinico S. Donato
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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