FP-GCA
Clinical, Neurophysiological and Genetical Predictors of Consciousness Recovery and Functional Outcomes After Severe Acquired Brain Injuries
Sponsor study identifier
observational
520
1 country
1
Study Start
June 9, 2020
Actual (reported)Primary Completion
June 10, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 10, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 10, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 9, 2020
Actual (reported)July 17, 2020
Actual (reported)July 31, 2020
Actual (reported)June 10, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 10, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Consciousness recovery
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.
24 months
Tracheostomy weaning
Tracheostomy weaning will be reported as a dichotomic variable: decannulated yes/no
24 months
Total oral feeding recovery
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
24 months
Functional autonomy
Cognitive profile
24 months
Degree of social and occupational reintegration
24 months
Subjective and Objective Quality Of Life
24 months
All patients admitted in the participant IRU with a history of sABI and fulfilling our inclusion and exclusion criteria will be recruited.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
IRCCS-don Gnocchi Foundation
Florence, 50143, Italy
Bernat JL. Chronic disorders of consciousness. Lancet. 2006 Apr 8;367(9517):1181-92. doi: 10.1016/S0140-6736(06)68508-5.
Giacino JT, Ashwal S, Childs N, Cranford R, Jennett B, Katz DI, Kelly JP, Rosenberg JH, Whyte J, Zafonte RD, Zasler ND. The minimally conscious state: definition and diagnostic criteria. Neurology. 2002 Feb 12;58(3):349-53. doi: 10.1212/wnl.58.3.349.
Hirschberg R, Giacino JT. The vegetative and minimally conscious states: diagnosis, prognosis and treatment. Neurol Clin. 2011 Nov;29(4):773-86. doi: 10.1016/j.ncl.2011.07.009.
blood
Bahia Hakiki, MD, Phd
IRCCS Fondazione Don Carlo Gnocchi, Florence
First Submitted
July 17, 2020
First Posted
July 31, 2020
Study Start
June 9, 2020
Actual (reported)Primary Completion
June 10, 2023
Estimated (date passed)Erigo®Pro Coma Outcome Study - Study on the Effectiveness of a Robotic Tilt Table Device for Recovery of Consciousness
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
24 months
Time to decannulation
In decannulated patients, time between admission in the IRU and decannulation will be reported
24 months
Contact the study team to confirm eligibility.
Amantini A, Grippo A, Fossi S, Cesaretti C, Piccioli A, Peris A, Ragazzoni A, Pinto F. Prediction of 'awakening' and outcome in prolonged acute coma from severe traumatic brain injury: evidence for validity of short latency SEPs. Clin Neurophysiol. 2005 Jan;116(1):229-35. doi: 10.1016/j.clinph.2004.07.008.
Cavinato M, Freo U, Ori C, Zorzi M, Tonin P, Piccione F, Merico A. Post-acute P300 predicts recovery of consciousness from traumatic vegetative state. Brain Inj. 2009 Nov;23(12):973-80. doi: 10.3109/02699050903373493.
Portaccio E, Morrocchesi A, Romoli AM, Hakiki B, Taglioli MP, Lippi E, Di Renzone M, Grippo A, Macchi C; Intensive Rehabilitation Unit Study Group of the IRCCS Don Gnocchi Foundation, Italy. Improvement on the Coma Recovery Scale-Revised During the First Four Weeks of Hospital Stay Predicts Outcome at Discharge in Intensive Rehabilitation After Severe Brain Injury. Arch Phys Med Rehabil. 2018 May;99(5):914-919. doi: 10.1016/j.apmr.2018.01.015. Epub 2018 Feb 8.
Portaccio E, Morrocchesi A, Romoli AM, Hakiki B, Taglioli MP, Lippi E, Di Renzone M, Grippo A, Macchi C. Score on Coma Recovery Scale-Revised at admission predicts outcome at discharge in intensive rehabilitation after severe brain injury. Brain Inj. 2018;32(6):730-734. doi: 10.1080/02699052.2018.1440420. Epub 2018 Feb 26.
Scarpino M, Lolli F, Hakiki B, Atzori T, Lanzo G, Sterpu R, Portaccio E, Romoli AM, Morrocchesi A, Amantini A, Macchi C, Grippo A; Intensive Rehabilitation Unit Study Group of the IRCCS Don Gnocchi Foundation, Italy. Prognostic value of post-acute EEG in severe disorders of consciousness, using American Clinical Neurophysiology Society terminology. Neurophysiol Clin. 2019 Sep;49(4):317-327. doi: 10.1016/j.neucli.2019.07.001. Epub 2019 Jul 18.
Lammi MH, Smith VH, Tate RL, Taylor CM. The minimally conscious state and recovery potential: a follow-up study 2 to 5 years after traumatic brain injury. Arch Phys Med Rehabil. 2005 Apr;86(4):746-54. doi: 10.1016/j.apmr.2004.11.004.
Katz DI, Polyak M, Coughlan D, Nichols M, Roche A. Natural history of recovery from brain injury after prolonged disorders of consciousness: outcome of patients admitted to inpatient rehabilitation with 1-4 year follow-up. Prog Brain Res. 2009;177:73-88. doi: 10.1016/S0079-6123(09)17707-5.
Estraneo A, Moretta P, Loreto V, Lanzillo B, Santoro L, Trojano L. Late recovery after traumatic, anoxic, or hemorrhagic long-lasting vegetative state. Neurology. 2010 Jul 20;75(3):239-45. doi: 10.1212/WNL.0b013e3181e8e8cc. Epub 2010 Jun 16.
Lipsky RH, Lin M. Genetic predictors of outcome following traumatic brain injury. Handb Clin Neurol. 2015;127:23-41. doi: 10.1016/B978-0-444-52892-6.00003-9.
Kim BR, Kim HY, Chun YI, Yun YM, Kim H, Choi DH, Lee J. Association between genetic variation in the dopamine system and motor recovery after stroke. Restor Neurol Neurosci. 2016 Nov 22;34(6):925-934. doi: 10.3233/RNN-160667.
Sorbi S, Nacmias B, Piacentini S, Repice A, Latorraca S, Forleo P, Amaducci L. ApoE as a prognostic factor for post-traumatic coma. Nat Med. 1995 Sep;1(9):852. doi: 10.1038/nm0995-852. No abstract available.
Lanzillotta A, Pignataro G, Branca C, Cuomo O, Sarnico I, Benarese M, Annunziato L, Spano P, Pizzi M. Targeted acetylation of NF-kappaB/RelA and histones by epigenetic drugs reduces post-ischemic brain injury in mice with an extended therapeutic window. Neurobiol Dis. 2013 Jan;49:177-89. doi: 10.1016/j.nbd.2012.08.018. Epub 2012 Aug 30.
Thelin EP, Nelson DW, Vehvilainen J, Nystrom H, Kivisaari R, Siironen J, Svensson M, Skrifvars MB, Bellander BM, Raj R. Evaluation of novel computerized tomography scoring systems in human traumatic brain injury: An observational, multicenter study. PLoS Med. 2017 Aug 3;14(8):e1002368. doi: 10.1371/journal.pmed.1002368. eCollection 2017 Aug.
Mateen BA, Hill CS, Biddie SC, Menon DK. DNA Methylation: Basic Biology and Application to Traumatic Brain Injury. J Neurotrauma. 2017 Aug 15;34(16):2379-2388. doi: 10.1089/neu.2017.5007. Epub 2017 Jun 28.
Scarpino M, Lolli F, Hakiki B, Lanzo G, Sterpu R, Atzori T, Portaccio E, Draghi F, Amantini A, Grippo A; Intensive Rehabilitation Unit Study Group of the IRCCS Don Gnocchi Foundation, Italy. EEG and Coma Recovery Scale-Revised prediction of neurological outcome in Disorder of Consciousness patients. Acta Neurol Scand. 2020 Sep;142(3):221-228. doi: 10.1111/ane.13247. Epub 2020 Apr 14.
Hakiki B, Liuzzi P, Romoli AM, Draghi F, Maccanti D, De Nisco A, Burali R, Toci T, Grippo A, Scarpino M, Mannini A, Magliacano A, Estraneo A, Comanducci A, Navarro J, Tramonti C, Carli V, Balbi P, Macchi C, Cecchi F. Predictors of Recovering Full Consciousness: Results From a Prospective Multisite Italian Study. Eur J Neurol. 2025 Apr;32(4):e70138. doi: 10.1111/ene.70138.
Draghi F, Pancani S, De Nisco A, Romoli AM, Maccanti D, Burali R, Grippo A, Macchi C, Cecchi F, Hakiki B. Implications of the Consciousness State on Decannulation in Patients With a Prolonged Disorder of Consciousness. Arch Phys Med Rehabil. 2024 Sep;105(9):1691-1699. doi: 10.1016/j.apmr.2024.05.006. Epub 2024 May 10.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 10, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 5, 2020
Record last verified: 2020-07
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