Status:
UNKNOWN
Connectivity in Cranioplasty
Lead Sponsor:
Azienda Usl di Bologna
Collaborating Sponsors:
Ministero della Salute, Italy
Conditions:
Acquired Brain Injury
Traumatic Brain Injury
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
An Exploratory Interventional study to assess the effects of cranioplasty on brain network connectivity, neuropsychological and motor functioning in patients with severe acquired brain injury with pre...
Detailed Description
BACKGROUND: Cranioplasty (CP) refers to the surgical reconstruction of the cranial defect secondary to Decompressive Craniectomy (DC). The aim of this intervention is not only to restore cranial cosme...
Eligibility Criteria
Inclusion
- Diagnosis of sABI, a neurological condition due to a severe acquired brain damage (i.e., traumatic brain injury, ischemic stroke, hemorrhagic stroke) with a coma lasting at least 24 hours, according to a Glasgow Coma Scale equal or lower than 8 and/or complex and severe neurological disabilities treatable only in high specialty neurehabilitative settings.
- Early DC, within 24 h;
- Age between 18 and 75 years;
- Intra-hospital rehabilitation setting (ordinary hospitalization or day hospithal);
- Informed consent agreement.
Exclusion
- Medical instability at enrollment, defined as the acute onset of an unexplained derangement of vital parameters (i.e., temperature, blood pressure, pulse rate, respiratory rate, oxygen saturation, level of responsiveness) outside the normal range (for example, fever, acute internist conditions, etc.) and/or the onset of any new medical condition requiring unexpected additional diagnostic procedures and treatments (for example, severe pain, reduction of urinary output, etc.);
- Post-traumatic agitation;
- Dehiscence, in progress, of the DC surgical wound;
- CP already performed;
- Magnetic Resonance Imaging (MRI) absolute contraindications.
Key Trial Info
Start Date :
October 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 27 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05440682
Start Date
October 27 2020
End Date
April 27 2023
Last Update
July 1 2022
Active Locations (1)
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1
Irccs - Istituto Delle Scienze Neurologiche
Bologna, Italy, 40139