Vagal Nerve Stimulation to Treat Disorders of Consciousness

Launched by UNIVERSITY OF MILANO BICOCCA · Nov 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called transcutaneous auricular vagal nerve stimulation (taVNS) to see if it can help improve consciousness in patients who have disorders of consciousness, such as coma or minimally conscious state. The researchers want to find out if this treatment can lead to better behavioral scores or an improved level of awareness compared to a sham (fake) stimulation. Participants in the study will receive taVNS or sham stimulation twice a day for 60 minutes during the acute phase of their condition and daily during their rehabilitation phase.

To be eligible for this trial, participants must be at least 18 years old and have a diagnosis related to acquired brain damage, such as a coma or other altered states of consciousness. They should also have intact ear skin and be available to use the stimulation device. However, certain patients, such as those with severe health issues requiring intensive treatment or those who are pregnant, are not eligible to participate. Overall, participants can expect to undergo stimulation treatments while being closely monitored for any changes in their consciousness and recovery.

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.