Clinical Trial

Vagal Nerve Stimulation to Treat Disorders of Consciousness

Study acronym: REVELATION
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07077135
Lead Sponsor Fondazione IRCCS San Gerardo dei Tintori
Conditions Disorder of Consciousness
Enrollment 106 participants
Start Date 2025-09-01
Primary Completion 2028-03-01 (estimated)
Study Completion 2028-09-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-22