Peripheral Nerve Stimulation for Prognostic and Diagnostic Biomarker Identification in Disorders of Consciousness

Launched by FONDAZIONE DON CARLO GNOCCHI ONLUS · Feb 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how certain brain signals can help doctors better understand and diagnose patients who have severe brain injuries and are experiencing Disorders of Consciousness, which means they may not be aware of their surroundings or unable to respond. The goal is to find specific biological markers, or "biomarkers," that can help distinguish between different types of these disorders and predict how well patients might recover over time.

To participate, patients must be over 18 years old and have experienced a severe brain injury, such as from a car accident, stroke, or cardiac arrest. Caregivers or family members will need to provide consent for participation. During the study, participants will have a special test called an EEG while their median nerve is stimulated. This test helps measure brain activity and gather important information about their condition. The trial is currently recruiting participants, and anyone interested should discuss it with their healthcare provider for more information.

Gender

ALL

Eligibility 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.