Neurostimulation for the Relief of Acute Bronchoconstriction

NCT00762931 | Completed Results

• 1 other identifier: BC-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Asthma

Keywords

bronchoconstriction; neuromodulation; neurostimulation; vagus nerve stimulation; vagal nerve stimulation; nVNS; VNS; non invasive; gammacore

Outcome Measures

Primary Outcomes (1)

• Safety- Number of Participants With Adverse Events

  Safety- Number of participants that reported Adverse Events

  2 weeks

Secondary Outcomes (1)

• Improvement of Common Measures of Breathing Performance, Forced Expiry Volume in 1second (FEV1).

  60 minutes

Study Arms (1)

Resolve Stimulator and Proximity Lead

EXPERIMENTAL

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

Interventions

Resolve Stimulator and Proximity Lead DEVICE

An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation

Resolve Stimulator and Proximity Lead

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ElectroCore INC: lead

Study Sites (6)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Washington University School of Medicine, Barnes-Jewish Hospital,

St Louis, Missouri, 63110, United States

Location

Dorrington Medical Associates

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Affairs electroCore LLC
• Organization: electroCore LLC

clinical@electrocorellc.com

+1 973 355 6683

Study Officials

• JP Errico

  ElectroCore INC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2008
• First Posted: September 30, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 15, 2018
• Results First Posted: May 15, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)