Vagal Nerve Stimulation to Treat Disorders of Consciousness
ConditionDisorder of Consciousness
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione IRCCS San Gerardo dei Tintori
About this trial
This interventional study aims to assess the clinical efficacy of transcutaneous auricular vagal nerve stimulation (taVNS) against sham stimulation on the recovery of consciousness in patients with disorders of consciousness. The main question it aims to answer is: will taVNS improve patients' behavioral scores or will it produce an improvement in the diagnosed level of consciousness? Researchers will compare the results with non-stimulated unconscious patients to see if the re-gain of consciousness is faster in the treated group.
Participants will undergo taVNS stimulation using the Parasym device or sham stimulation will be applied from the time of enrolment.
Active stimulations will be carried out for 60 minutes twice daily during the acute phase and daily during the rehabilitation phase.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- stimulated group
- Sham (No Treatment)
Treatment groups
106 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov