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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01532817
Recruitment Status : Completed
First Posted : February 15, 2012
Results First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Information provided by (Responsible Party):
ElectroCore LLC

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.

Condition or disease Intervention/treatment Phase
Asthma Device: AlphaCore Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-Invasive Neurostimulation of the Vagus Nerve With the AlphaCore™ Device, for the Relief of Acute Bronchoconstriction Due to Asthma
Study Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: alphacore
noninvasive neurostimulation of the vagus nerve
Device: AlphaCore
A single 90 second stimulation to the vagus nerve on the right side of the neck

Primary Outcome Measures :
  1. Safety- Number of Participants With Adverse Events [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  1. Is able to give written Informed Consent.
  2. Is between the ages of 18 and 65 years, male or female.
  3. Has a known history of mild to moderate asthma for at least 1 year as defined by GINA Guidelines.
  4. Is using a short acting beta-agonist for relief/rescue of asthma..
  5. 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.


  1. Has a history of lung cancer, chronic obstructive pulmonary disease (COPD), or other co-morbidity associated with irreversible narrowing of the airways.
  2. Has an abscess or other infection or lesion (including lymphadenopathy) at the AlphaCore™ treatment site.
  3. 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).
  4. Has suspected or confirmed sepsis.
  5. Has a clinically significant irregular heart rate or rhythm.
  6. Has experienced recent clinically significant changes in blood pressure, has uncontrolled high blood pressure, or is presently receiving pressors to maintain blood pressure.
  7. 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.
  8. Has a history of carotid endarterectomy or vascular neck surgery on the right side.
  9. Has been implanted with metal cervical spine hardware.
  10. Has a recent or repeated history of syncope.
  11. Has a recent or repeated history of seizures.
  12. Is pregnant or nursing, or of childbearing years and is unwilling to use an accepted form of birth control.
  13. Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
  14. 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).
  15. Is a relative of or an employee of the Investigator or the clinical study site.


  1. No changes have occurred in the patient's health or status relative to the original inclusion and exclusion criteria and the patient continues to be eligible for participation in the study.
  2. Either (i) develops subjective symptoms of asthma (wheezing, shortness of breath, cough) for which the patient would normally self-medicate with a short acting beta agonist, and/or (ii) documents a drop of 20% from screening PEF scores as recorded in their patient diary.
  3. At Visit 2, FEV1 is the same or lower than the screening FEV1 previously measured at visit 1 or the PEF is the same or lower than the screening previously measured at Visit 1.


  1. The patient self-administered a short-acting beta agonist within 6 hours prior to onset of asthma symptoms.
  2. The patient induced an asthma exacerbation by withholding their pre-treatment medication used for exercise-induced bronchoconstriction (EIB).
  3. Has signs and symptoms of asthma instability at Visit 2:

    • Lung Function: FEV1 < 50 % predicted.
    • Signs and symptoms of extreme respiratory distress at rest.
    • Rapid deterioration in respiratory status (sudden change in respiratory rate, decrease in oxygen saturation, change in consciousness, etc.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01532817

United States, California
Allergy and Asthma
San Diego, California, United States, 92123
United States, Minnesota
Minneapolis, Minnesota, United States, 55402
United States, Oklahoma
Vital Prospects Clinical Research Institute
Tulsa, Oklahoma, United States, 74136
Sponsors and Collaborators
ElectroCore LLC
Study Chair: John Erico ElectroCore LLC

Responsible Party: ElectroCore LLC Identifier: NCT01532817     History of Changes
Other Study ID Numbers: BC-US-06
First Posted: February 15, 2012    Key Record Dates
Results First Posted: April 9, 2018
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases