Asthma
Conditions
Brief summary
The purpose of this pilot study is to collect preliminary clinical data related to the safety and preliminary clinical benefits of non-invasive vagal nerve stimulation with the AlphaCore™ device for the relief of acute bronchoconstriction due to asthma. Up to 30 subjects who meet all inclusion/exclusion criteria and consent to participate in the study may be enrolled at up to 5 investigational (study) sites. The study sites are clinic settings capable of treating any potential complications of bronchoconstriction, an acute exacerbation of asthma, and any emergencies associated with use of the investigational device.
Detailed description
Subjects will be screened, consented and enrolled at the first visit. Subjects will return to the second visit where they are experiencing shortness of breath and will be treated with the alphacore. Breathing and vital signs will be measured before, during and after the stimulation. The study is concluded on the third visit, 7 days later.
Interventions
DEVICEAlphaCore
A single 90 second stimulation to the vagus nerve on the right side of the neck
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
VISIT 1 1. Is able to give written Informed Consent. 2. Is between the ages of 18 and 65 years, male or female. 3. Has a known history of mild to moderate asthma for at least 1 year as defined by GINA Guidelines. 4. Is using a short acting beta-agonist for relief/rescue of asthma.. 5. At Visit 1, demonstrates current or historical (within 1 year) FEV1 reversibility of at least 12% (and 200ml) or greater within 15-30 minutes following administration of 4 inhalations of albuterol.
Exclusion criteria
VISIT 1 1. Has a history of lung cancer, chronic obstructive pulmonary disease (COPD), or other co-morbidity associated with irreversible narrowing of the airways. 2. Has an abscess or other infection or lesion (including lymphadenopathy) at the AlphaCore™ treatment site. 3. Has known or suspected moderate to severe atherosclerotic cardiovascular disease, carotid artery disease (e.g. bruits or history of TIA or CVA) or congestive heart failure (CHF). 4. Has suspected or confirmed sepsis. 5. Has a clinically significant irregular heart rate or rhythm. 6. Has experienced recent clinically significant changes in blood pressure, has uncontrolled high blood pressure, or is presently receiving pressors to maintain blood pressure. 7. Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant. 8. Has a history of carotid endarterectomy or vascular neck surgery on the right side. 9. Has been implanted with metal cervical spine hardware. 10. Has a recent or repeated history of syncope. 11. Has a recent or repeated history of seizures. 12. Is pregnant or nursing, or of childbearing years and is unwilling to use an accepted form of birth control. 13. Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days. 14. Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner). 15. Is a relative of or an employee of the Investigator or the clinical study site. INCLUSION CRITERIA: VISIT 2 1. No changes have occurred in the patient's health or status relative to the original inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety- Number of Participants With Adverse Events | From time subject signs the consent through the 1-week follow-up visit | Safety- number of participants with adverse events, including device-related, serious or unanticipated |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alphacore noninvasive neurostimulation of the vagus nerve
AlphaCore: A single 90 second stimulation to the vagus nerve on the right side of the neck | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Alphacore |
|---|---|
| Age, Customized Age | 30 years |
| Race/Ethnicity, Customized Black | 8 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 17 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 10 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Safety- Number of Participants With Adverse Events
Safety- number of participants with adverse events, including device-related, serious or unanticipated
Time frame: From time subject signs the consent through the 1-week follow-up visit
Population: Open label study 30 participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alphacore | Safety- Number of Participants With Adverse Events | 10 Participants |