Clinical trial NCT01385306: Noninvasive Neurostimulation of the Vagus Nerve for the Relief of Acute Bronchoconstriction Due to Asthma
Official title: Noninvasive Neurostimulation of the Vagus Nerve With the AlphaCore System for the Relief of Acute Bronchoconstriction Due to Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Asthma
Lead sponsor: ElectroCore INC
Sponsor class: INDUSTRY
First posted: 2011-06-30
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 30 days
Secondary outcomes:
measure: Number of Participants With a Change in FEV1 (Forced Expiratory Volume at 1 Second) of 12% or More From Baseline to 30 Minutes
timeFrame: 30 minutes
measure: Improvement in Dyspnea Score of at Least 1.5 Points From Baseline to 30 Minutes
timeFrame: 30 minutes
measure: Time to Discharge From the Emergency Department
timeFrame: Duration of stay in emergency room - up to approximately 6 hours.
measure: Number of Participants With Requirement for Concomitant Medications
timeFrame: Duration of stay in emergency room, up to approximately 6 hours
Other outcomes:
Locations:
city: Kuils River
country: South Africa
facility: Kuilsriver Hospital
state: Cape Town
city: Panorama
country: South Africa
facility: Panorama Mediclinic
state: Cape Town
city: Pinelands
country: South Africa
facility: Life Vincent Pallotti Hospital
state: Cape Town
city: Stellenbosch
country: South Africa
facility: Cape Gate Medi-Clinic Hospital
state: Cape Town
city: Cape Town
country: South Africa
facility: Christiaan Barnard Memorial Hospital
Study officials:
name: Elmin Steyn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: unafiliated
name: Zunaid Mohammed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: unafiliated
name: Robert Johnson
role: PRINCIPAL_INVESTIGATOR
affiliation: unafiliated
name: Dale Cilliers
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.