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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
ElectroCore LLC
ClinicalTrials.gov Identifier:
NCT01385306
First received: June 17, 2011
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Bronchoconstriction
Asthma
Device: AlphaCore System
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ElectroCore LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • Improvement of FEV1 [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Improvement with Dyspnea Score [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Time to discharge from the emergency department [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • Requirement for concomitant medications [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: June 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: AlphaCore System
Non-invasive neurostimulation of the vagus nerve

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385306

Locations
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
Investigators
Principal Investigator: Elmin Steyn, MD
Principal Investigator: Zunaid Mohammed, MD unafiliated
Principal Investigator: Robert Johnson unafiliated
Principal Investigator: Dale Cilliers unafiliated
  More Information

No publications provided

Responsible Party: ElectroCore LLC
ClinicalTrials.gov Identifier: NCT01385306     History of Changes
Other Study ID Numbers: BC-SA-01
Study First Received: June 17, 2011
Last Updated: December 12, 2011
Health Authority: South Africa: Department of Health

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

ClinicalTrials.gov processed this record on October 19, 2014