Identifying biomarkers in patients with Disorders of Consciousness
Microneurography and Microneurostimulation for Prognosis and Rehabilitation of Disorders of Consciousness
This study is trying to find important signs in the brain that can help doctors better understand and predict the outcomes for patients with severe brain injuries who are not fully conscious.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 1 site (Florence, FI) |
| Trial ID | NCT06845800 on ClinicalTrials.gov |
What this trial studies
This observational study integrates clinical, anamnestic, and innovative neurophysiological data to evaluate their impact on diagnosing and predicting outcomes for patients with Disorders of Consciousness due to severe brain injury. Participants will undergo EEG examinations during near-nerve stimulation of the median nerve, alongside the collection of demographic and clinical data. The study aims to identify high-relevance biomarkers for distinguishing patient subcategories and to assess their prognostic value over medium and long-term periods.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with severe acquired brain injuries resulting in altered states of consciousness.
Not a fit: Patients with a history of previous neurological diseases or those who have experienced acute brain injuries more than three months prior may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and prognostic assessments for patients with Disorders of Consciousness.
How similar studies have performed: While the approach of using neurophysiological data for prognostic and diagnostic purposes is established, the specific methodology of this study may offer novel insights into Disorders of Consciousness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years, both sexes; * Severe acquired brain injury (regardless of etiology); * Patients with severe alteration of consciousness state due to severe acquired brain injury of various etiologies (Cardiac Arrest, Traumatic Brain Injury, Cerebral Ischemia or Hemorrhage); * Informed consent signature by family member/caregiver/legal guardian. Exclusion Criteria: * Time since the acute event greater than 3 months; * Previous neurological diseases; * Previous acute brain injuries, psychiatric disorders, neurodegenerative diseases, neoplasms, severe systemic diseases; * Modified Barthel Index pre-event \< 50; * Unstable medical conditions.
Where this trial is running
Florence, FI
- IRCCS Fondazione Don Carlo Gnocchi — Florence, Fi, Italy (Recruiting)
Study contacts
- Study coordinator: Andrea Mannini
- Email: amannini@dongnocchi.it
- Phone: +39 055 73931
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.