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Transcutaneous Auricular Vagus Nerve Stimulation for Recovery of Consciousness After Surgery for Spontaneous Intracerebral Hemorrhage
Sponsor: Beijing Tiantan Hospital
Summary
Disorders of consciousness are common after surgery for severe spontaneous intracerebral hemorrhage and are associated with high mortality, disability, and long-term dependence. Transcutaneous auricular vagus nerve stimulation (taVNS) is a noninvasive neuromodulation technique that may enhance arousal-network activity, modulate secondary brain injury, and promote recovery of consciousness. This multicenter, prospective, double-blind, randomized, sham-controlled trial will enroll 160 adults aged 18 to 75 years who underwent hematoma evacuation within 48 hours after spontaneous intracerebral hemorrhage and have a Glasgow Coma Scale score of 5 to 9 on postoperative day 5 while not sedated. Participants will be assigned 1:1 to active taVNS or sham stimulation for 8 hours once daily for 6 weeks. The primary outcome is the proportion of participants who remain in a disorder of consciousness (unresponsive wakefulness syndrome/vegetative state or minimally conscious state) at postoperative day 90, determined using the Coma Recovery Scale-Revised by blinded assessors. Nested mechanistic substudies will investigate how taVNS may affect recovery through multimodal assessment of structural and functional brain networks, cerebral perfusion, electrophysiology, autonomic function, and circulating or cerebrospinal-fluid biomarkers. Depending on clinical stability, site capability, sample availability, and additional consent, assessments may include computed tomography, computed tomography angiography and perfusion, structural and functional magnetic resonance imaging, diffusion imaging, arterial spin labeling, electroencephalography, blood samples, and cerebrospinal fluid obtained during clinically indicated procedures.
Official title: Efficacy and Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation for Promoting Recovery of Consciousness After Surgery for Spontaneous Intracerebral Hemorrhage: A Multicenter, Prospective, Double-Blind, Randomized, Sham-Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2026-08
Completion Date
2027-12
Last Updated
2026-08-12
Healthy Volunteers
No
Interventions
Active Transcutaneous Auricular Vagus Nerve Stimulation
Active taVNS is delivered to the left ear at a frequency of 25 Hz, a pulse width of 500 microseconds, and a current intensity of 0.8-1.5 mA. Stimulation alternates between 30 seconds on and 30 seconds off for a total wearing period of 8 hours once daily. Treatment begins after randomization on postoperative day 5 (±1 day) and continues for 6 weeks.
Sham Transcutaneous Auricular Vagus Nerve Stimulation
The sham device is worn at the same left-ear location and for the same schedule as active taVNS (8 hours once daily for 6 weeks), but no electrical current is delivered.
Locations (1)
Capital Medical University Affliated Beijing Tiantan Hospital, Beijing, Beijing
Beijing, China