Vagus Nerve Stimulation for Coma
What You Need to Know Before You Apply
What is the purpose of this trial?
Some patients with severe traumatic brain injury cannot respond at the bedside, yet about 1 in 4 may be aware but unable to show it - a hidden state called cognitive motor dissociation. This study tests a gentle, non-invasive treatment delivered through clips on the left ear that stimulates two nerves at once: the vagus nerve at the inner ear (taVNS) and the trigeminal nerve at the outer ear (taTNS). Each nerve has separately been shown to help people with disorders of consciousness recover, but they have not been combined before. All enrolled patients receive the stimulation for one hour a day, with continuous heart and oxygen monitoring and a pain-protection check used to keep the dose safe. The study measures recovery two ways: the Coma Recovery Scale-Revised (CRS-R), scored by clinicians, and SeeMe, an automated camera system that detects tiny command-driven movements the eye cannot see.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Experimental: Dual-site auricular stimulation (taVNS + taTNS). All enrolled participants receive active vagal and trigeminal auricular stimulation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sima Mofakham
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
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