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
1 other identifier
interventional
30
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable asthma
Started Jan 2012
Shorter than P25 for not_applicable asthma
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 10, 2012
CompletedFirst Posted
Study publicly available on registry
February 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
April 9, 2018
CompletedApril 9, 2018
April 1, 2018
4 months
February 10, 2012
March 7, 2018
April 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Safety- Number of Participants With Adverse Events
Safety- number of participants with adverse events, including device-related, serious or unanticipated
From time subject signs the consent through the 1-week follow-up visit
Study Arms (1)
alphacore
EXPERIMENTALnoninvasive neurostimulation of the vagus nerve
Interventions
A single 90 second stimulation to the vagus nerve on the right side of the neck
Eligibility Criteria
You may qualify if:
- Is able to give written Informed Consent.
- Is between the ages of 18 and 65 years, male or female.
- Has a known history of mild to moderate asthma for at least 1 year as defined by GINA Guidelines.
- Is using a short acting beta-agonist for relief/rescue of asthma..
- At Visit 1, demonstrates current or historical (within 1 year) FEV1 reversibility of at least 12% (and 200ml) or greater within 15-30 minutes following administration of 4 inhalations of albuterol.
You may not qualify if:
- Has a history of lung cancer, chronic obstructive pulmonary disease (COPD), or other co-morbidity associated with irreversible narrowing of the airways.
- Has an abscess or other infection or lesion (including lymphadenopathy) at the AlphaCore™ treatment site.
- Has known or suspected moderate to severe atherosclerotic cardiovascular disease, carotid artery disease (e.g. bruits or history of TIA or CVA) or congestive heart failure (CHF).
- Has suspected or confirmed sepsis.
- Has a clinically significant irregular heart rate or rhythm.
- Has experienced recent clinically significant changes in blood pressure, has uncontrolled high blood pressure, or is presently receiving pressors to maintain blood pressure.
- Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
- Has a history of carotid endarterectomy or vascular neck surgery on the right side.
- Has been implanted with metal cervical spine hardware.
- Has a recent or repeated history of syncope.
- Has a recent or repeated history of seizures.
- Is pregnant or nursing, or of childbearing years and is unwilling to use an accepted form of birth control.
- Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
- Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner).
- Is a relative of or an employee of the Investigator or the clinical study site.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ElectroCore INClead
Study Sites (3)
Allergy and Asthma
San Diego, California, 92123, United States
CRI
Minneapolis, Minnesota, 55402, United States
Vital Prospects Clinical Research Institute
Tulsa, Oklahoma, 74136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Affairs
- Organization
- electroCore LLC
Study Officials
- STUDY CHAIR
John Erico
ElectroCore INC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2012
First Posted
February 15, 2012
Study Start
January 1, 2012
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
April 9, 2018
Results First Posted
April 9, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share