Vagus Nerve Stimulation to Treat Moderate Traumatic Brain Injury
United States14 participantsStarted 2016-10
Plain-language summary
The purpose of this single-center, prospective, randomized (1:1), double-blind, sham-controlled parallel-arm pilot study is to provide initial evidence of use of the noninvasive vagus nerve stimulator for treatment in patients recovering from concussion and moderate traumatic brain injury to improve clinical recovery. The study compares the safety and effectiveness of an active gammaCore treatment against a sham treatment.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Written Informed Consent obtained by Subject or Subject's proxy.
✓. Is between the ages of 18 and 60 years, male or female.
✓. Meets the criteria of the Head Injury Interdisciplinary Special Interest Group of the American Congress of Rehabilitation Medicine, which defines a head injury as a traumatically induced physiologic disruption of brain function, as manifested by one of the following:
✓. Meets the criteria for moderate TBI as defined by the Head Injury Interdisciplinary Special Interest Group of the American Congress of Rehabilitation Medicine, which are as follows:
✓. Has had a craniotomy, but those with hydrocephalus or active intracranial pressure elevation will be excluded.
✓. Able to accurately communicate the sensation of amplitude of intensity by the stimulation treatment with the GammaCore device.
✓. Has a stable orthopedic or other traumatic body injury.
✓. Is capable of completing all study assessments.
Exclusion criteria
✕. Has an active DNR/DNI (do not resuscitate/ do not intubate) request.
✕. Has dissent among family members / next of kin regarding level of care.
✕. Has a penetrating injury.
✕. Has concurrent active severe medical problems or conditions, which could prevent survival during the course of the study.