Asthma
Conditions
Keywords
bronchoconstriction, neuromodulation, neurostimulation, vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, non invasive, gammacore
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.
Interventions
DEVICEResolve Stimulator and Proximity Lead
An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation
Sponsors
ElectroCore INC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety- Number of Participants With Adverse Events | 2 weeks | Safety- Number of participants that reported Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Common Measures of Breathing Performance, Forced Expiry Volume in 1second (FEV1). | 60 minutes | 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%. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Resolve Stimulator and Proximity Lead: An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Resolve Stimulator and Proximity Lead |
|---|---|
| Age, Continuous | 41 years |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Black | 18 Participants |
| Race/Ethnicity, Customized Hispanic and white | 1 Participants |
| Race/Ethnicity, Customized Hispanic Black | 1 Participants |
| Race/Ethnicity, Customized Hispanic Latino | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 2 Participants |
| Region of Enrollment United States | 25 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 25 |
| other Total, other adverse events | 8 / 25 |
| serious Total, serious adverse events | 11 / 25 |
Outcome results
Primary
Safety- Number of Participants With Adverse Events
Safety- Number of participants that reported Adverse Events
Time frame: 2 weeks
Population: Safety
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Resolve Stimulator and Proximity Lead | Safety- Number of Participants With Adverse Events | 16 Participants |
Secondary
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%.
Time frame: 60 minutes
Population: Safety population. 1 subject result missing due to no stimulation performed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Resolve Stimulator and Proximity Lead | Improvement of Common Measures of Breathing Performance, Forced Expiry Volume in 1second (FEV1). | 19 Participants |