Personality Traits as a Variable in the Recovery of Patients With Acquired Brain Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversita di Verona
About this trial
This study aims to evaluate the potential effects of premorbid personality on the short- and long-term global cognitive recovery in patients with severe acquired brain injury (sABI) or stroke.
The secondary aims are to assess the effects of premorbid personality on the sort- and long-term recovery in autonomy (disability), cognitive functions, psycho-behavioral functioning, motor skills, and social participation. Evaluate the incidence of premorbid personality alterations. Investigate personality changes 12-18 months after the neurological event.
Eligibility criteria
Qualifiers
Severe Acquired Brain Injury (sABI) of traumatic or non-traumatic etiology; the term sABI includes acute brain injuries of traumatic or non-traumatic origin (vascular, infectious, metabolic, or anoxic), in which the patient initially presents with a coma state (Glasgow Coma Scale - GCS less than 8) and simultaneously exhibits motor, sensory, cognitive, and/or behavioral impairments.
Ischemic or hemorrhagic stroke without features of Severe Acquired Brain Injury (sABI) (Glasgow Coma Scale [GCS] score ≥ 8 and no alteration of consciousness).
7 and 90 days for Severe Acquired Brain Injury (sABI) patients
3 and 30 days for stroke patients
Disqualifiers
Pre-existing neurological pathology
Severe aphasia or severe inattention that precludes administration of the tests required by the protocol, as identified during cognitive screening.
Patients with a language barrier due to insufficient proficiency in Italian.
Trial design
Treatments tested in this trial
- Motor, cognitive and psychological assessment
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Universita di Verona
Lead sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Sponsor institution
Azienda USL Toscana Sud Est
Collaborator
Centro Cardinal Ferrari, Fontanellato, Parma
Collaborator
Fondazione IRCCS Santa Lucia, Roma, Italy
Collaborator
Azienda Unita Sanitaria Locale di Piacenza
Collaborator
Azienda Sanitaria dell'Alto Adige
Collaborator
Azienda Ospedaliero, Universitaria Pisana
Collaborator
Azienda Sanitaria Locale CN1 Cuneo
Collaborator
Istituto S.Anna Crotone
Collaborator
Montecatone Rehabilitation Institute S.p.A., Imola (Italy)
Collaborator
IRCCS Don Carlo Gnocchi di Firenze
Collaborator
IRCCS Don Carlo Gnocchi Milano
Collaborator
CRT Montevarchi Arezzo
Collaborator
Source ClinicalTrials.gov