gammaCore Non-Invasive Vagus Nerve Stimulation (nVNS) Improves Neurobehavioral Outcomes in a Model of Traumatic Brain Injury
The study design included low dose nVNS, high dose nVNS, and control arms, and stimulated 5 (low dose nVNS) or 10 (high dose nVNS) times over an hour, beginning 30 minutes post-TBI in a rodent model. Magnetic Resonance Imaging (MRI) studies on Day 1 and 7 revealed smaller brain lesion (damage) volume among the nVNS groups compared with the control group. On Day 1, these abnormal volume changes were 13% and 55% (p<0.05) smaller in the lower dose and higher dose nVNS groups, respectively, compared with the control group. By Day 7, nVNS decreased the size of the cortical lesion (injury) by 35% and 89% (p<0.05) in the low dose and high dose nVNS groups, respectively, compared with the control group. The control group showed significant deficits in 3 common neurobehavioral assessments including rotarod, anxiety, and modified beam walking performances. All these deficits were significantly reduced (p<0.05) in the high dose nVNS group on Day 1 and the two anxiety indices were also reduced on Day 7 post-injury compared with the control group. MRI data suggest that the benefits may be caused by a decrease in the deformation and swelling of brain tissue after TBI. Additional work on the potential benefits of nVNS on TBI will be funded by an Exploratory/Development Research Grant (R21) from the
Traumatic brain injury is a significant cause of death and disability worldwide.
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company's current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.
For more information, visit www.electrocore.com.
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the neck. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.
gammaCore (nVNS) is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.
gammaCore is contraindicated for patients if they:
- Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Safety and efficacy of gammaCore have not been evaluated in the following patients:
- Adolescent patients with congenital cardiac issues
- Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
- Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
- Pediatric patients (less than 12 years)
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
For more information, please visit gammaCore.com.
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore's business prospects and clinical and product development plans (including with respect to enrollment in ongoing studies); its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the issuance of
1 Corps, K.N., Roth, T.L. and McGavern, D.B. (2015). Inflammation and neuroprotection in traumatic brain injury. JAMA Neurology 72, 355-362.
3 Summers, C.R., Ivins, B. and Schwab, K.A. (2009). Traumatic brain injury in