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

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Device: AlphaCore

• Registration Number: NCT01532817
• Lead Sponsor: ElectroCore INC

Brief 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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-15
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Disposition First Submitted: 2016-02-23
• Disposition First Submitted QC: 2018-01-18
• Disposition First Posted: 2018-01-25
• Results First Submitted: 2018-03-07
• Status Verified: 2018-04
• Results First Submitted QC: 2018-04-06
• Last Update Submitted: 2018-04-06
• Results First Posted: 2018-04-09
• Last Update Posted: 2018-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
alphacore	AlphaCore	noninvasive neurostimulation of the vagus nerve

Primary Outcome Measures

Name	Time	Method
Safety- Number of Participants With Adverse Events	From time subject signs the consent through the 1-week follow-up visit	Safety- number of participants with adverse events, including device-related, serious or unanticipated

Trial Locations

Locations (3)

Allergy and Asthma; 🇺🇸 San Diego, California, United States

Vital Prospects Clinical Research Institute; 🇺🇸 Tulsa, Oklahoma, United States

CRI; 🇺🇸 Minneapolis, Minnesota, United States