The study will be based in West Haven, Connecticut, and enroll up to 100 veterans with the headache disorder.
ElectroCore has announced that the U.S. Department of Veterans Affairs (VA) is initiating a new study investigating the use of its gammaCore Sapphire device for the treatment of post-traumatic headache (PTH).1
Jason Sico, MD, MHS, FAHA, FAAN, national director, VA Headache Centers of Excellence (HCoE) Program, and associate professor, neurology and internal medicine, Yale School of Medicine, said in a statement that “PTH is one of the most common presentations among veterans who come to our VA Headache Centers of Excellence around the United States. Last year the Veterans Health Administration was caring for more than 140,000 veterans diagnosed with headache related to head trauma.”
GammaCore is a handheld, non-invasive vagus nerve stimulation (nVNS) medical therapy device. It was approved for the treatment of episodic cluster headache pain in 2017, and this indication was later expanded to migraine pain in January 2018 and adjunctive preventive treatment of cluster headache in December 2018. The portable device can be self-administered as needed and is placed over the vagus nerve in the neck, which is stimulated via a mild electrical signal.2
PTH is the most common consequence of mild traumatic brain injury (TBI) and accounts for approximately 4% of all symptomatic headache disorders. People with PTH often experience comorbidities such as anxiety and depression, which are leading causes of disability worldwide. It is estimated that over 350,000 service members have PTH resulting from TBI sustained in combat, including from blast wave injuries.
“We have been using gammaCore nVNS successfully in veterans suffering from cluster headache and migraine at our center,” added primary investigator Emmanuelle Schindler, MD, PhD, medical director, HCoE, VA Connecticut Healthcare System, and assistant professor, neurology, Yale School of Medicine, to the statement. “This will be among the first randomized controlled trials (RCT) for PTH, and we look forward to demonstrating how gammaCore nVNS can help our veterans with PTH.”
The study, known as GAP-PTH, will be randomized, multi-center, double-blind, and sham-controlled. It will be directed by the VA HCoE at the West Haven VA Medical Center in Connecticut and will enroll up to 100 veterans.
“GammaCore is being used across the Department of Veterans Affairs and Department of Defense for both cluster and migraine headache and we believe that the same mechanisms of action that support the efficacy of gammaCore in primary headaches could also provide relief to our servicemen, servicewomen, and veterans suffering from post-traumatic headache,” added Eric Lieblier, senior vice president, neurology, electroCore, to the statement.
Most recently, in February 2021, the FDA cleared the expansion of gammaCore use to include the preventive treatment of migraine in adolescent patients aged between 12 and 17 years. This expansion came after RCT data in adolescents (n = 9) with migraine with aura, in which 46.8% (n = 22) of 47 treated attacks were successfully resolved without the use of any acute rescue medication. There were no device-related adverse events (AEs) reported in the preliminary study.3
“Migraine is a very common disease in adolescents that can affect them at home, school, and socially. gammaCore, which can be used acutely to treat migraine attacks, or when used daily can decrease the number of attacks, is an exciting treatment that I look forward to offering to my adolescent patients,” Andrew Hershey, MD, PhD, FAHS, Endowed Chair, and director of neurology, Cincinnati Children’s Medical Center, and professor of pediatrics and neurology, University of Cincinnati College of Medicine, said in a statement at that time.