Predictors of Better Outcomes After Severe Acquired Brain Injuries
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- STATUS
- Recruiting
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- days left to enroll
- 69
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- participants needed
- 520
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- sponsor
- Fondazione Don Carlo Gnocchi Onlus
Summary
Severe
Description
- Background
After a severe
Study aim:
The present project aims at identifying patient profiles with better long-term outcome in order to plan tailored therapeutic interventions.
The patient profiles will be drawn up by gathering patient's demographic (age, gender, social
and educational level), anamnestic (aetiology and time post-brain
On the basis of the above mentioned stratification of patients by this multimodal approach, the present study aimed to
- Investigate the possible association of certain profiles with the consciousness recovery at the time of discharge from the Intensive Rehabilitation Unit (IRU), at 1 year and 2 years from the acute event
- Investigate the possible association of certain profiles with the functional outcomes at the time of discharge from the Intensive Rehabilitation Unit (IRU), at 1 year and 2 years from the acute event.
- Investigate the possible association of certain profiles with the long-term cognitive profile and the level of familiar and social participation at 1 year and 2 years from the acute event.
Setting , population and methods:
The proposed study is a longitudinal multi-location prospective observational cohort study.
Four centers of the Don Carlo Gnocchi Foundation will participate (Florence, La Spezia, Milan
and Sant'Angelo dei Lombardi and the neurogenetics laboratory of the University of Florence,
Department of Medical and Experimental Sciences, Neurology). The enrollment phase will last 3
years (June 2020-June 2023). 520 patients with severe
All patients admitted in the participant IRU with a history of sABI within 4 months, aged
18+, presenting a signed informed consent signature for the participation to the study and
for the
A multidimodal evaluation including clinical examinations and neurophysiological assessments will be performed by skilled professionals. The study foresees four steps in the late acute phase and two in the long-term phase: 1) at the study entry time (T0), 2) at three months from T0 (T1) 3) at 6 months from T0 (T2) 4) at discharge (T3) 5) at 12 months from the acute event (T4) 6) at 24 months from the acute event.
Clinical assessment including :
- Consciousness assessment using CRS-R
- Care severity profile: including the comorbidity assessed thought the Cumulative Illness
Rating Scale (CIRS), the presence of medical devices,
sepsis occurrence during the IRU stay,neurosurgery interventions,bedsores ,epileptic event and other complications Functional evaluation using the following scales: ERBI, GOS-E, DRS, FIM, PAINED pain scale, TCT, Ashworth, FOIS- Neurocognitive profile evaluation using the Galveston Orientation and
Amnesia Test (GOAT), the Level of Cognitive Functioning (LCF) and the International Classification of Functioning, Disability and Health (ICF), ABS, AES and Cognitive Reserve Index (CRI)
Multimodal neurophysiological evaluation including:
- Standard EEG recording at rest. EEG background activity and reactivity will be classified according to recently proposed diagnostic criteria for DoC and to American Clinical Neurophysiology Society Critical Care EEG Terminology.
- Motor and sensory
nerve conduction studies. Sensory nerve action potentials, and compound muscle action potentials (CMAP) will be evaluated. Muscular activity at rest and when possible during reflex contraction will be assessed. - PEM:
Transcranial magnetic stimulation (TMS) will be performed according to the standard criteria of the International Federation of Clinical Neurophysiology. MEP will be recorded from abductor digiti minimi and tibialis anterior muscles and size of MEP measured as MEP/CMAP amplitude ratio. - Bilateral
upper limb SEP will be recorded according to the International Federation of Clinical Neurophysiology. The presence or absence of N20/P25 cortical components will be evaluated.
Genetic assessment Genomic DNA will be obtained from EDTA-whole venous blood sample by
Automated Systems QiaCube (Qiagen). The
Statistic analysis:
All collected data will be analyzed using a machine learning algorithm, creating, for each patient, a risk profile for the possible consciousness recovery and functional autonomy.
On the basis of the results of this study, partecipant will build on a "decision support tool" for future sABI patients afferent to the Intensive Rehabilitative Unit, in order to plan personalized rehabilitative and therapeutic interventions, allowing therefore an optimization of resources (costs and resources) for National Health Service
Details
Condition |
|
---|---|
Age | 18years - 100years |
Treatment |
|
Clinical Study Identifier | NCT04495192 |
Sponsor | Fondazione Don Carlo Gnocchi Onlus |
Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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