Predictors of Better Outcomes After Severe Acquired Brain Injuries (FP-GCA)
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|ClinicalTrials.gov Identifier: NCT04495192|
Recruitment Status : Recruiting
First Posted : July 31, 2020
Last Update Posted : August 5, 2020
|Condition or disease||Intervention/treatment|
|Brain Injuries Disorder of Consciousness||Genetic: Genetic analysis of different single nucleotide polymorphisms on ApoE, BDNF and DRD2 genes assessment|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||520 participants|
|Target Follow-Up Duration:||24 Months|
|Official Title:||Clinical, Neurophysiological and Genetical Predictors of Consciousness Recovery and Functional Outcomes After Severe Acquired Brain Injuries|
|Actual Study Start Date :||June 9, 2020|
|Estimated Primary Completion Date :||June 10, 2023|
|Estimated Study Completion Date :||June 10, 2025|
Patients affected by severe Acquired Brain Injury
All patients admitted in the participant IRU with a history of sABI and fulfilling our inclusion and exclusion criteria will be recruited.
Genetic: Genetic analysis of different single nucleotide polymorphisms on ApoE, BDNF and DRD2 genes assessment
Genomic DNA will be obtained from EDTA-whole venous blood sample by Automated Systems QiaCube (Qiagen). The genetic analysis of 5 different single nucleotide polymorphisms on ApoE, BDNF and DRD2 genes will be performed by HRM analyses and direct sequencing on Automatic Genetic Analyzer. All the aliquots will be amplified by a real-time PCR. The genetic polymorphism data will be compared to sex- and age-matched control of the DNA banking of the neurogenetic Laboratory of Florence Hospital.
- Consciousness recovery [ Time Frame: 24 months ]The Consciousness recovery will be measured throught the italian version of the CRS-R performed for at least 5 time during one week to avoid a misdiagnosis due to consciousness fluctuations.Consciousness recovery is defined as CRS_R >23 and Improvement Responsiveness will be registred for patients transitioning from UWS to MCS or E-MCS, and from MCS to E-MCS.
- Tracheostomy weaning [ Time Frame: 24 months ]Tracheostomy weaning will be reported as a dichotomic variable: decannulated yes/no
- Total oral feeding recovery [ Time Frame: 24 months ]The swallowing severity will be assessed throught the Oral feeding recovery measured by Functional Oral Intake Scale (FOIS) scoring from 1 (severe dysphagia) to 7(absence of dysphagia). The outcome of "oral feeding recovery" corrispond to Functional Oral Intake Scale>4
- Functional autonomy [ Time Frame: 24 months ]Functional autonomy measured by Glasgow Outcome Scale Expanded scoring between 1 (death) and 8 (complete functional recovery). A good autonomy is defined for Glasgow Outcome Scale Expanded >4
- Time to decannulation [ Time Frame: 24 months ]In decannulated patients, time between admission in the IRU and decannulation will be reported
- Cognitive profile [ Time Frame: 24 months ]The cognitive profile will be assessed firstly investigating the "post-event amnesia" by the Galveston Orientation & Amnesia Test. The date of "post-event amnesia" resolution will be reported when the Galveston Orientation & Amnesia Test score >75 for two consecutive days
- Degree of social and occupational reintegration [ Time Frame: 24 months ]Degree of social and occupational reintegration assessed by the Community Integration Questionnaire (CIQ). Minimum score is 10 and maximum score is 50. A higher score indicates a higher comunity integration
- Subjective and Objective Quality Of Life [ Time Frame: 24 months ]
The Quality of Life after Brain Injury (QoLibri) scale allows to measure both the quality of life perceived by both the patient and the caregiver. Quality of Life after Brain Injury (QoLibri) scores are reported on a 0-100 scale.
0=worst possible quality of life and 100=best possible quality of life.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495192
|Contact: Bahia Hakiki, MD, Phdfirstname.lastname@example.org|
|IRCCS-don Gnocchi Foundation||Recruiting|
|Florence, Italy, 50143|
|Contact: Maria Chiara Carozza, Prof. email@example.com|
|Principal Investigator:||Bahia Hakiki, MD, Phd||IRCCS Fondazione Don Carlo Gnocchi, Florence|