N/A
N=25
Neurostimulation for the Relief of Acute Bronchoconstriction
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00762931 ↗Enrolled (actual)
25
Serious AEs
44.0%
Results posted
May 2018
Primary outcome: Primary: Safety- Number of Participants With Adverse Events — 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resolve Stimulator and Proximity Lead (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ElectroCore INC
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety- Number of Participants With Adverse Events |
16 | — |
| SECONDARY Improvement of Common Measures of Breathing Performance, Forced Expiry Volume in 1second (FEV1). |
19 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00762931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.