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

Noninvasive Neurostimulation of the Vagus Nerve With the AlphaCore System for the Relief of Acute Bronchoconstriction Due to Asthma

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.

Study Overview

• Status: Terminated
• Conditions: Asthma
• Intervention / Treatment: Device: AlphaCore System

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa, 8001
    • Christiaan Barnard Memorial Hospital
  • Cape Town
    • Kuils River, Cape Town, South Africa, 7580
      • Kuilsriver Hospital
    • Panorama, Cape Town, South Africa, 7500
      • Panorama MediClinic
    • Pinelands, Cape Town, South Africa, 7405
      • Life Vincent Pallotti Hospital
    • Stellenbosch, Cape Town, South Africa, 7600
      • Cape Gate Medi-Clinic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Change in FEV1 (Forced Expiratory Volume at 1 Second) of 12% or More From Baseline to 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.)	30 minutes
Improvement in Dyspnea Score of at Least 1.5 Points From Baseline to 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.	30 minutes
Time to Discharge From the Emergency Department	Time to discharge from the emergency department post stimulation	Duration of stay in emergency room - up to approximately 6 hours.
Number of Participants With Requirement for Concomitant Medications	Requirement for concomitant medications. Medications administered in the emergency department pre and post stimulation	Duration of stay in emergency room, up to approximately 6 hours

Collaborators and Investigators

• Sponsor: ElectroCore INC
• Investigators: Principal Investigator: Elmin Steyn, MD; Principal Investigator: Zunaid Mohammed, MD, unafiliated; Principal Investigator: Robert Johnson, unafiliated; Principal Investigator: Dale Cilliers, unafiliated

Publications and helpful links

General Publications

• Steyn E, Mohamed Z, Husselman C. Non-invasive vagus nerve stimulation for the treatment of acute asthma exacerbations-results from an initial case series. Int J Emerg Med. 2013 Mar 19;6(1):7. doi: 10.1186/1865-1380-6-7.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: June 17, 2011
• First Submitted That Met QC Criteria: June 29, 2011
• First Posted (Estimate): June 30, 2011

Study Record Updates

• Last Update Posted (Actual): November 9, 2018
• Last Update Submitted That Met QC Criteria: October 11, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: BC-SA-01