Noninvasive Neurostimulation of the Vagus Nerve for the Relief of Acute Bronchoconstriction Due to Asthma (BC-SA-01)

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: NCT01385306
Recruitment Status : Terminated (Slow enrollment)
First Posted : June 30, 2011
Last Update Posted : February 19, 2016
Information provided by (Responsible Party):
ElectroCore LLC

Brief Summary:
The objective of this feasibility research study is to gather preliminary clinical data regarding the safety and potential clinical benefit of noninvasive neurostimulation of the vagus nerve with the AlphaCore™ system for the relief of acute bronchoconstriction due to asthma.

Condition or disease Intervention/treatment Phase
Asthma Device: AlphaCore System Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Noninvasive Neurostimulation of the Vagus Nerve With the AlphaCore System for the Relief of Acute Bronchoconstriction Due to Asthma
Study Start Date : June 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Device: AlphaCore System
Non-invasive neurostimulation of the vagus nerve

Primary Outcome Measures :
  1. The safety of the AlphaCore system will be determined according to the type and incidence of device or procedure related adverse events, as well as the severity of these events. [ Time Frame: 30 minutes ]
    Subjects will be assessed for vitals and breathing/respiratory through 90 minutes after the first stimulation. Subjects will also be seen at 7 days and have a phone call at 30 days from the date of the stimulation procedure.

Secondary Outcome Measures :
  1. Improvement of FEV1 [ Time Frame: 30 minutes ]
  2. Improvement with Dyspnea Score [ Time Frame: 30 minutes ]
  3. Time to discharge from the emergency department [ Time Frame: 90 minutes ]
  4. Requirement for concomitant medications [ Time Frame: 90 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Is between the ages of 18 and 70 years.
  2. Has been admitted to an emergency care facility with a working diagnosis of bronchoconstriction due to asthma.
  3. Has an FEV1<60% predicted.
  4. Is available and willing to return for an office visit at 7 days and participate in a 30-day telephone call from time of discharge from the ED.
  5. Is able to give written Informed Consent, or his/her legally authorized representative is available to give written Informed Consent.

Exclusion Criteria:

  1. Has a history of lung cancer, chronic obstructive pulmonary disease (COPD), or other co-morbidity due to irreversible narrowing of the airways.
  2. Is at risk of imminent respiratory collapse:

    • Lung Function: FEV1 < 25% predicted
    • Signs and symptoms of extreme respiratory distress at rest, such as accessory muscle use, chest retraction
    • Consciousness State: Drowsy, confused
    • Rapid deterioration in respiratory status (sudden change in respiratory rate, decrease in oxygen saturation, change in consciousness, etc).
  3. Has an abscess or other infection or lesion (including lymphadenopathy) at the therapy head placement site.
  4. Has known or suspected atherosclerotic cardiovascular disease, carotid artery disease (e.g. bruits or history of TIA or CVA) or congestive heart failure (CHF).
  5. Has suspected or confirmed sepsis.
  6. Has a clinically significant irregular heart rate or rhythm.
  7. Clinically significant changes in blood pressure or is receiving pressors to maintain blood pressure.
  8. Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
  9. Has a history of carotid endarterectomy or vascular neck surgery on the right side.
  10. Has been implanted with metal cervical spine hardware.
  11. Has a condition that would interfere with VAS Dyspnea self-assessment.
  12. Is pregnant.
  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).

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): NCT01385306

South Africa
Kuilsriver Hospital
Kuils River, Cape Town, South Africa, 7580
Panorama Mediclinic
Panaroma, Cape Town, South Africa, 7500
Life Vincent Pallotti Hospital
Pinelands, Cape Town, South Africa, 7405
Cape Gate Medi-Clinic Hospital
Stellenbosch, Cape Town, South Africa, 7600
Christiaan Barnard Memorial Hospital
Cape Town, South Africa, 8001
Sponsors and Collaborators
ElectroCore LLC
Principal Investigator: Elmin Steyn, MD
Principal Investigator: Zunaid Mohammed, MD unafiliated
Principal Investigator: Robert Johnson unafiliated
Principal Investigator: Dale Cilliers unafiliated

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: ElectroCore LLC Identifier: NCT01385306     History of Changes
Other Study ID Numbers: BC-SA-01
First Posted: June 30, 2011    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016

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