Connectivity in Cranioplasty (NCT05440682) | Clinical Trial Compass
UnknownNot Applicable
Connectivity in Cranioplasty
Italy10 participantsStarted 2020-10-27
Plain-language 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-, post-cranioplasty and 6 months follow-up assessments.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Changes in Mean Diffusivity values:
Timeframe: pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP