NCT01532817

Relief of Acute Bronchoconstriction/Asthma Using the Non-Invasive AlphaCore Device

Non-Invasive Neurostimulation of the Vagus Nerve With the AlphaCore™ Device, for the Relief of Acute Bronchoconstriction Due to Asthma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: ElectroCore INC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot study is to collect preliminary clinical data related to the safety and preliminary clinical benefits of non-invasive vagal nerve stimulation with the AlphaCore™ device for the relief of acute bronchoconstriction due to asthma. Up to 30 subjects who meet all inclusion/exclusion criteria and consent to participate in the study may be enrolled at up to 5 investigational (study) sites. The study sites are clinic settings capable of treating any potential complications of bronchoconstriction, an acute exacerbation of asthma, and any emergencies associated with use of the investigational device.

Detailed description

Subjects will be screened, consented and enrolled at the first visit. Subjects will return to the second visit where they are experiencing shortness of breath and will be treated with the alphacore. Breathing and vital signs will be measured before, during and after the stimulation. The study is concluded on the third visit, 7 days later.

Conditions

• Asthma

Interventions

Type	Name	Description
DEVICE	AlphaCore	A single 90 second stimulation to the vagus nerve on the right side of the neck

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-02-15
• Last updated: 2018-04-09
• Results posted: 2018-04-09

Locations

3 sites across 1 country: United States