Abstract Details

Title Real-world Use of Non-invasive Vagus Nerve Stimulation for Acute Treatment of Pain in Episodic Cluster Headache Attacks: Results From a Patient Registry

Topic Headache

Presentation(s) S38 - Headache: Clinical Trials II (1:55 PM-2:06 PM)

Poster/Presentation
Number 006

Background Cluster headache (CH) has few safe, effective, and practical treatment options. nVNS (gammaCore) can relieve CH-associated pain within 15 minutes and has been cleared by the US Food and Drug Administration for acute treatment of episodic CH and migraine pain.

Objective The gammaCore^® Patient Registry (GPR), a platform for patients to prospectively record experiences with non-invasive vagus nerve stimulation (nVNS), was created to expand understanding of the benefits and challenges of real-world nVNS use.

Design/Methods At select US headache centers, adults diagnosed with episodic CH and prescribed nVNS were invited to participate in the GPR and asked to provide baseline information. Participants were trained on self-treatment with nVNS and the use of a tracker for collection of data on nVNS usage and the frequency, severity (0-4 scale; 0=no pain), and duration of their CH attacks.

Results Between July 2017 and June 2018, 14 patients (50% women) provided data on nVNS use for 116 attacks, with a mean of 3.69 (standard error, 0.46) stimulations used per attack. Mean pain score was 2.68 (95% confidence interval [CI], 2.43-2.92) at attack onset and 1.30 (95% CI, 0.97-1.64) 30 minutes after initial treatment; mean reduction in pain score at that time was 1.38 (95% CI, 1.13-1.64). Patients subjectively self-reported that nVNS reduced pain in 82.0% of attacks (95% CI, 56.8%-94.1%); whereas their objective scores before and after treatment suggested that nVNS reduced pain in 86.9% of attacks (95% CI, 70.0%-95.0%). Of the 116 nVNS-treated attacks, 69.8% (95% CI, 53.0%-82.7%) had either mild or no pain at 30 minutes.

Conclusions For the vast majority of attacks, nVNS reduced pain severity within 30 minutes. These real-world findings demonstrate the practical use of nVNS and complement evidence from clinical trials supporting its efficacy for acute treatment of episodic CH attacks.

Authors/Disclosures
Abraham J. Nagy, MD (Nevada Headache Institute) PRESENTER	No disclosure on file
	No disclosure on file
	No disclosure on file
Eric J. Liebler (ElectroCore LLC)	Eric J. Liebler has received personal compensation for serving as an employee of electroCore. Eric J. Liebler has received stock or an ownership interest from electroCore.
Jessica Ailani, MD, FAAN (Medstar Georgetown Neurology)	Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eli Lilly. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as a Consultant for Gore. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merz. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as a Consultant for Scilex. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dr. Reddy. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vectura. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as a Consultant for Aeon. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Linpharma. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Self Magazine. The institution of Dr. Ailani has received research support from Ipsen. The institution of Dr. Ailani has received research support from Parema. The institution of Dr. Ailani has received research support from Lundbeck. Dr. Ailani has a non-compensated relationship as a Executive Board Member with American Headache Society that is relevant to AAN interests or activities.

��ɫ��

��ɫ��