Neurostimulation for the Relief of Acute Bronchoconstriction

The goal of this study is to validate design for the Resolve™ Stimulator and Proximity Electrode and the associated procedure to quickly and safely place an electrode into the neck, in the vicinity of the vagus nerve by a physician in either the Emergency Department or other appropriate hospital inpatient setting (e.g., ICU). The secondary goal is to confirm that the electrical signal being delivered via this electrode rapidly counters bronchoconstriction and improves airway flow.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: Resolve Stimulator and Proximity Lead

Detailed Description

The present study is to evaluate the safety of a new neurostimulator device, the Resolve Stimulator and Proximity Lead™, which comprises an external electrical signal generator coupled to temporary electrode that is percutaneously inserted in the neck.

Sponsor believes, based on animal testing data provided as well as consultations with physicians who regularly treat patients suffering from attacks of acute bronchoconstriction in ER and inpatient hospital settings, that this device could be used in the skilled care hospital setting to help rapidly relax the smooth muscle in the airway, relieving a clinically significant portion of the bronchoconstriction suffered by patients experiencing moderate to severe asthma attacks, allowing more effective delivery of inhaled medications to restore the patient to his or her baseline respiration status.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine, Barnes-Jewish Hospital,
  • Texas
    • Houston, Texas, United States, 77030
      • Dorrington Medical Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male / Female, Age 18-65
• Subject declares a medical history of asthma or sufficient prior clinical experience/records exists to confirm the subject has received a diagnosis of bronchoconstriction
• Completed >1 hrs of conventional breathing and related medication treatments without improvement in FEV1 to > 70% predicted
• Able to give Informed Consent

Exclusion Criteria:

• Scaring / abscess other problems with neck at electrode placement site
• Known or suspected carotid artery disease (i.e. bruits or history of stenosis)
• Suspected or confirmed coagulopathy
• Suspected or confirmed sepsis
• Irregular heart rate, rhythm
• Receiving pressors to maintain blood pressure
• Presently implanted 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
• Allergy to local anesthetics used for placement of the lead
• History of lung cancer, emphysema, chronic obstructive pulmonary disease, or other comorbidity that might otherwise compromise the expected air flow volumes in the lungs

• At risk of imminent respiratory collapse

  • Lung Function: FEV1 < 40% predicted
  • Signs and Symptoms: Extreme symptoms at rest, accessory muscle use, chest retraction
  • Alert State: Drowsy, confused
• Treatment with anti-cholinergic medications within 4 hours of enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Resolve Stimulator and Proximity Lead; An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation, all subjects will receive active treatment	Device: Resolve Stimulator and Proximity Lead; An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety- Number of Participants With Adverse Events	Safety- Number of participants that reported Adverse Events	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of Common Measures of Breathing Performance, Forced Expiry Volume in 1second (FEV1).	An assessment of Forced Expiry Volume in 1second (FEV1) measurements were taken throughout the course of treatment (15,30 and 60 minutes). Peak FEV1 measurements were recorded for each subject, and the number of minutes the subject had received treatment at the time of peak FEV1. The threshold for improvement was set at 12% over baseline at any of the time points (15,30 and 60 minutes). Outcome measure data indicates the number of subjects above 12%.	60 minutes

Collaborators and Investigators

• Sponsor: ElectroCore INC
• Investigators: Study Director: JP Errico, ElectroCore INC

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (ACTUAL): September 1, 2010
• Study Completion (ACTUAL): October 1, 2010

Study Registration Dates

• First Submitted: September 29, 2008
• First Submitted That Met QC Criteria: September 29, 2008
• First Posted (ESTIMATE): September 30, 2008

Study Record Updates

• Last Update Posted (ACTUAL): May 15, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: neuromodulation; neurostimulation; vagus nerve stimulation; bronchoconstriction; VNS; vagal nerve stimulation; nVNS; non invasive; gammacore
• Other Study ID Numbers: BC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO