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

October 11, 2018 updated by: ElectroCore INC

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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.)
30 minutes
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.
30 minutes
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
Duration of stay in emergency room - up to approximately 6 hours.
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
Duration of stay in emergency room, up to approximately 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ElectroCore INC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BC-SA-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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