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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
Sponsor:
Information provided by (Responsible Party):
Bahia Hakiki, Fondazione Don Carlo Gnocchi Onlus

Brief Summary:
Severe Acquired Brain Injury is defined as a traumatic, post-anoxic, vascular or other brain damage that causes coma for at least 24 hours and leads to permanent disability with sensorial, motor, cognitive or compartmental impairment. In this context, an accurate characterization of individual patients' profile in terms of neuronal damage, potential for neuroplasticity, neurofunctional and clinical state could allow to plan tailored rehabilitation and care pathway on the basis of solid prognostic information, also for optimizing resources of the National Health care systems and enhance ethical decisions. Patient profiling should encompass measures and procedures easily available at the bedside, and with affordable time, resource, and money-costs to determine a real impact on National Health systems. The aim of the study is identifying patient profiles in terms of clinical, neurophysiological and genetical aspects with better long-term outcome in order to plan tailored therapeutic interventions.

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 520 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. Tracheostomy weaning [ Time Frame: 24 months ]
    Tracheostomy weaning will be reported as a dichotomic variable: decannulated yes/no

  3. 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

  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

  5. Time to decannulation [ Time Frame: 24 months ]
    In decannulated patients, time between admission in the IRU and decannulation will be reported


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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
blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe Acquired Brain Injuries admitted in the Intensive Rehabilitative Unit (IRU) of the four participant don Gnocchi Foundation Centers (Florence, La Spezia, Milano and Sant'Angelo dei Lombardi) fulfilling the inclusion criteria will be included.
Criteria

Inclusion Criteria:

  • patients admitted with a history of severe Acquired Brain Injury within 4 months,
  • aged 18+,
  • signed informed consent signature for the participation to the study
  • signed informed consent signature for the participation to for the genetic analysis

Exclusion Criteria:

  • patients admitted with a history of severe Acquired Brain Injury more then 4 months
  • Absence of informed consent to participate in the study

Information from the National Library of Medicine

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


Contacts
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Contact: Bahia Hakiki, MD, Phd 0039-333-4018388 bhakiki@dongnocchi.it

Locations
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Italy
IRCCS-don Gnocchi Foundation Recruiting
Florence, Italy, 50143
Contact: Maria Chiara Carozza, Prof.       mccarrozza@dongnocchi.it   
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus
Investigators
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Principal Investigator: Bahia Hakiki, MD, Phd IRCCS Fondazione Don Carlo Gnocchi, Florence
Publications:

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Responsible Party: Bahia Hakiki, Neurologist, MD, Ph D, Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT04495192    
Other Study ID Numbers: 16606_OSS
First Posted: July 31, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bahia Hakiki, Fondazione Don Carlo Gnocchi Onlus:
Rehabilitation
Machine Learning
Brain-derived neurotrophic factor
Apolipoprotein E
Cognitive Reserve
Predictive Factors
Additional relevant MeSH terms:
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Brain Injuries
Consciousness Disorders
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Neurobehavioral Manifestations
Neurologic Manifestations
Neurocognitive Disorders
Mental Disorders