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

NCT ID: NCT01385306

Last Updated: 2018-11-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-07-31

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.

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.

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

AlphaCore System

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

Group Type: EXPERIMENTAL

AlphaCore System

Intervention Type: DEVICE

Non-invasive neurostimulation of the vagus nerve

Interventions

AlphaCore System

Non-invasive neurostimulation of the vagus nerve

Intervention Type: DEVICE

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ElectroCore INC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elmin Steyn, MD

Role: PRINCIPAL_INVESTIGATOR

Zunaid Mohammed, MD

Role: PRINCIPAL_INVESTIGATOR

unafiliated

Robert Johnson

Role: PRINCIPAL_INVESTIGATOR

unafiliated

Dale Cilliers

Role: PRINCIPAL_INVESTIGATOR

unafiliated

Locations

Kuilsriver Hospital

Kuils River, Cape Town, South Africa

Panorama Mediclinic

Panorama, Cape Town, South Africa

Life Vincent Pallotti Hospital

Pinelands, Cape Town, South Africa

Cape Gate Medi-Clinic Hospital

Stellenbosch, Cape Town, South Africa

Christiaan Barnard Memorial Hospital

Cape Town, , South Africa

Countries

South Africa

References

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.

Reference Type: DERIVED

PMID: 23510361 (View on PubMed)

Other Identifiers

BC-SA-01

Identifier Type: -

Identifier Source: org_study_id