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

NCT01385306 | Terminated Results DMC

• 1 other identifier: BC-SA-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 5

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants With a Change in FEV1 (Forced Expiratory Volume at 1 Second) of 12% or More From Baseline to 30 Minutes

  30 minutes

• Improvement in Dyspnea Score of at Least 1.5 Points From Baseline to 30 Minutes

  30 minutes

• Time to Discharge From the Emergency Department

  Duration of stay in emergency room - up to approximately 6 hours.

• Number of Participants With Requirement for Concomitant Medications

  Duration of stay in emergency room, up to approximately 6 hours

Study Arms (1)

AlphaCore System

EXPERIMENTAL

non-invasive vagus nerve stimulation (nVNS) using the AlphaCore System

Device: AlphaCore System

Interventions

AlphaCore System DEVICE

Non-invasive neurostimulation of the vagus nerve

AlphaCore System

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is between the ages of 18 and 70 years.
• Has been admitted to an emergency care facility with a working diagnosis of bronchoconstriction due to asthma.
• Has an FEV1\<60% predicted.
• 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.
• Is able to give written Informed Consent, or his/her legally authorized representative is available to give written Informed Consent.

You may not qualify if:

• Has a history of lung cancer, chronic obstructive pulmonary disease (COPD), or other co-morbidity due to irreversible narrowing of the airways.
• 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).
• Has an abscess or other infection or lesion (including lymphadenopathy) at the therapy head placement site.
• Has known or suspected 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.
• Clinically significant changes in blood pressure or is receiving pressors to maintain blood pressure.
• 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.
• Has a history of carotid endarterectomy or vascular neck surgery on the right side.
• Has been implanted with metal cervical spine hardware.
• Has a condition that would interfere with VAS Dyspnea self-assessment.

Sponsors & Collaborators

• ElectroCore INC: lead

Study Sites (5)

Kuilsriver Hospital

Kuils River, Cape Town, 7580, South Africa

Location

Panorama Mediclinic

Panorama, Cape Town, 7500, South Africa

Location

Life Vincent Pallotti Hospital

Pinelands, Cape Town, 7405, South Africa

Location

Cape Gate Medi-Clinic Hospital

Stellenbosch, Cape Town, 7600, South Africa

Location

Christiaan Barnard Memorial Hospital

Cape Town, 8001, South Africa

Location

Related Publications (1)

• 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.

  PMID: 23510361 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Affairs
• Organization: electroCore LLC

clinical@electrocorellc.com

+1 973 355 6683

Study Officials

• Elmin Steyn, MD

  PRINCIPAL INVESTIGATOR

• Zunaid Mohammed, MD

  unafiliated

  PRINCIPAL INVESTIGATOR

• Robert Johnson

  unafiliated

  PRINCIPAL INVESTIGATOR

• Dale Cilliers

  unafiliated

  PRINCIPAL INVESTIGATOR

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: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 30, 2011
• Study Start: June 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 9, 2018
• Results First Posted: October 10, 2018

Record last verified: 2018-10

Locations

ZA (5)