Vagus Nerve Stimulation to Treat Moderate Traumatic Brain Injury

Completed · Phase 1 · Has a placebo group

Conditions studied: Traumatic Brain Injury, Acute Brain Injuries

In brief

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.

Key facts

Study ID

NCT02974959

Run by

CentraCare

People needed

14

Starts

2016-10-01

Expected to finish

2020-11-01

Last updated by the study team

2021-02-04

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Any period of loss of consciousness (LOC),
• Any loss of memory for events immediately before or after the accident,
• Any alteration in mental state at the time of the accident,
• Focal neurologic deficits, which may or may not be transient.
• 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:
• Length of stay at least 48 hours,
• Glasgow Coma Scale (GCS score of 9-12 or higher)
• Operative intracranial lesion,
• Abnormal CT scan findings.
• 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.
• Agrees to use the GammaCore device as intended and follow all of the requirements of the study, including follow-up visits.
• Agrees to record usage of the GammaCore device, all required study data, and report any adverse effects to the sponsor/investigator within 24 hours of any such adverse event.

You may not qualify if…

• 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.
• Has pre-existing central nervous system disease or associated comorbidities that may not allow for an 18-week follow-up visit.
• Has an abscess, infection or lesion (including lymphadenopathy) at the gammaCore treatment site.
• Has known or suspected moderate to severe atherosclerotic cardiovascular disease, carotid artery disease (e.g. bruits or history of TIA or CVA).
• Has a clinically significant irregular heart rate or rhythm.
• Has uncontrolled hypertension (systolic bp > 200 or diastolic bp >100), recent (within the last 3 months) heart attack, recent (within the last 3 months) stroke, known aortic aneurysm, or congestive heart failure (CHF).
• Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
• Has a history of significant carotid endarterectomy, vagotomy, dysaesthesia or vascular neck surgery on either side of the neck.
• Has been implanted with metal cervical spine hardware.
• Has a recent or repeated history of syncope.
• Has a recent or repeated history of seizures.
• Has known clotting disorder or hemophilia
• Has anemia (hb<12)
• Is pregnant or nursing, or of childbearing potential and is unwilling to use an accepted form of birth control (hormonal, barrier method, surgical, or abstention or is at least two years post-menopause).
• Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
• Is an employee of the clinical study site or a relative of the Investigator.
• Has an abnormal baseline electrocardiogram (ECG), including second and third degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation or clinically significant premature ventricular contraction.
• Has a known history or suspicion of substance abuse or addiction.

Where it is running

• Hennepin County Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.