Identifying factors for better recovery after severe brain injuries
Clinical, Neurophysiological and Genetical Predictors of Consciousness Recovery and Functional Outcomes After Severe Acquired Brain Injuries
Fondazione Don Carlo Gnocchi Onlus · NCT04495192
This study is trying to find out which factors can help people recover better after severe brain injuries by looking at their age, gender, and genetics.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 520 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus (other) |
| Locations | 1 site (Florence) |
| Trial ID | NCT04495192 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify patient profiles that predict better long-term outcomes following severe acquired brain injuries (sABI). It focuses on gathering clinical, neurophysiological, and genetic data to tailor rehabilitation and care pathways for affected individuals. By analyzing factors such as age, gender, and specific genetic markers, the study seeks to enhance prognostic information and optimize healthcare resources. The goal is to improve recovery strategies for patients in various states of consciousness following their injuries.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced a severe acquired brain injury within the last four months.
Not a fit: Patients who have had a severe acquired brain injury for more than four months or who do not provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized rehabilitation strategies that improve recovery outcomes for patients with severe brain injuries.
How similar studies have performed: While there have been studies on prognostic factors in acute phases of brain injuries, this approach focusing on long-term outcomes and genetic profiling is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Florence
- IRCCS-don Gnocchi Foundation — Florence, Italy (RECRUITING)
Study contacts
- Principal investigator: Bahia Hakiki, MD, Phd — IRCCS Fondazione Don Carlo Gnocchi, Florence
- Study coordinator: Bahia Hakiki, MD, Phd
- Email: bhakiki@dongnocchi.it
- Phone: 0039-333-4018388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Injuries, Disorder of Consciousness, Rehabilitation, Machine Learning, Brain-derived neurotrophic factor, Apolipoprotein E, Cognitive Reserve, Predictive Factors