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

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ClinicalTrials.gov Identifier: NCT01385306
Recruitment Status : Terminated (Slow enrollment)
First Posted : June 30, 2011
Results First Posted : October 10, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
ElectroCore INC

Study Description
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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 Not Applicable

Detailed Description:
The purpose of the study was to collect initial safety and efficacy information of use of the AlphaCore System by clinicians in an emergency setting as an adjunctive treatment to standard of care for the relief of acute bronchoconstriction. After consent was obtained and screening completed, subjects were stimulated two times, 30 minutes apart, for 90 seconds each. Subjects were assessed prior to and immediately post the first stimulation and at 15, 30, 60, and 90 minutes; follow was also conducted at day 7 and day 30.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
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

Arms and Interventions
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Arm Intervention/treatment
Experimental: AlphaCore System
non-invasive vagus nerve stimulation (nVNS) using the AlphaCore System
 Device: AlphaCore System
Non-invasive neurostimulation of the vagus nerve


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 30 days ]
    Subjects were assessed for adverse events for the duration of procedure. Subjects were also seen at 7 days and had a phone call at 30 days from the date of the stimulation procedure.


Secondary Outcome Measures :
  1. Number of Participants With a Change in FEV1 (Forced Expiratory Volume at 1 Second) of 12% or More From Baseline to 30 Minutes [ Time Frame: 30 minutes ]

    Improvement in FEV1 was defined as an increase of at least 12% compared with baseline (pre-first stimulation). The 30 minute measure was taken immediately after the second stimulation.

    (FEV1 measured as a percentage of normal, where greater that 80% is normal and less than 40% is severe degree of obstruction.)


  2. Improvement in Dyspnea Score of at Least 1.5 Points From Baseline to 30 Minutes [ Time Frame: 30 minutes ]
    Improvement in dyspnea was defined as at least 1.5 point decrease on a 10 point Visual Analogue Scale (VAS) compared with baseline (pre-first stimulation). Where 0 = no dyspnea and 10 = very severe dyspnea. The 30 minute measure was taken immediately after the second stimulation.

  3. Time to Discharge From the Emergency Department [ Time Frame: Duration of stay in emergency room - up to approximately 6 hours. ]
    Time to discharge from the emergency department post stimulation

  4. Number of Participants With Requirement for Concomitant Medications [ Time Frame: Duration of stay in emergency room, up to approximately 6 hours ]
    Requirement for concomitant medications. Medications administered in the emergency department pre and post stimulation


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

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).
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01385306


Locations
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South Africa
Kuilsriver Hospital
Kuils River, Cape Town, South Africa, 7580
Panorama Mediclinic
Panorama, 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 INC
Investigators
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Principal Investigator: Elmin Steyn, MD
Principal Investigator: Zunaid Mohammed, MD unafiliated
Principal Investigator: Robert Johnson unafiliated
Principal Investigator: Dale Cilliers unafiliated
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ElectroCore INC
ClinicalTrials.gov Identifier: NCT01385306    
Other Study ID Numbers: BC-SA-01
First Posted: June 30, 2011    Key Record Dates
Results First Posted: October 10, 2018
Last Update Posted: November 9, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases