Neurostimulation for the Relief of Acute Bronchoconstriction

Completed · Not applicable

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00762931

Run by

ElectroCore INC

People needed

25

Starts

2008-09-01

Expected to finish

2010-10-01

Last updated by the study team

2018-05-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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