Vagal Nerve Stimulation to Treat Disorders of Consciousness

Launched by FONDAZIONE IRCCS SAN GERARDO DEI TINTORI · Jul 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a treatment called transcutaneous auricular vagal nerve stimulation (taVNS) can help people with disorders of consciousness, such as coma or a minimally conscious state, recover awareness more quickly. The treatment involves using a small device to gently stimulate a nerve in the ear, which researchers hope will improve patients’ ability to respond and regain consciousness. The study will compare patients receiving the real nerve stimulation to those receiving a fake (sham) treatment to see if the active treatment leads to better recovery.

Adults who have recently experienced brain injury leading to coma or similar conditions may be eligible, as long as they have healthy skin on their ears and do not have certain serious health problems, implants like pacemakers, or are pregnant. Participants will receive the stimulation twice a day for one hour during the early phase of treatment and then once daily during rehabilitation. This study is not yet recruiting patients but aims to find out if this non-invasive therapy can support faster and better recovery of consciousness after severe brain injury.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years old;
• • any acquired cerebral damage of any known etiology;
• • diagnosis of coma, UWS, or MCS with the corresponding basal CRS-R (Coma Recovery Scale-Revised) score performed during the screening period from 7 to 15 days since admission in ICU;
• • intact ear skin;
• • availability of the device.
• Exclusion Criteria:
• • Patients with severe hemodynamic, respiratory, infectious, or neurological instability requiring active treatment requiring mechanical ventilation or vasoactive drugs or pending acute neurosurgical interventions;
• • Need for deep sedation, including general anesthetics (e.g., propofol) or a combination of central-acting sedatives;
• • Documented pregnancy;
• • Active implant (e.g., pacemaker, cochlear implant);
• • History of previous serious neurological disability before the brain injury;
• • Seizures or status epilepticus as cause sustaining the disorder of consciousness;
• • Patients already enrolled in another ongoing interventional trial.