Clinical trial NCT00762931: Neurostimulation for the Relief of Acute Bronchoconstriction
Official title: Neurostimulation for the Relief of Acute Bronchoconstriction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: bronchoconstriction
neuromodulation
neurostimulation
vagus nerve stimulation
vagal nerve stimulation
nVNS
VNS
non invasive
gammacore
Lead sponsor: ElectroCore INC
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety- Number of Participants With Adverse Events
timeFrame: 2 weeks
Secondary outcomes:
measure: Improvement of Common Measures of Breathing Performance, Forced Expiry Volume in 1second (FEV1).
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine, Barnes-Jewish Hospital,
state: Missouri
city: Houston
country: United States
facility: Dorrington Medical Associates
state: Texas
Study officials:
affiliation: ElectroCore INC
name: JP Errico
role: STUDY_DIRECTOR
References: