10 Participants NeededMy employer runs this trial

Vagus Nerve Stimulation for Coma

SM
Overseen BySima Mofakham, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sima Mofakham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

I am 18 years old or older.
Admission to the Neurology or Neurosurgical ICU
I have a recent brain injury with abnormal findings on a brain scan.
See 2 more

Exclusion Criteria

Implanted cardiac pacemaker, vagus nerve stimulator, or other active implanted device
I need increasing doses of medication to maintain my blood pressure.
I have a diagnosed heart rhythm problem.
See 3 more

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Dual-site auricular stimulation (taVNS + taTNS)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sima Mofakham

Lead Sponsor

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+