Asthma
Conditions
Brief summary
The objective of this feasibility research study is to gather preliminary clinical data regarding the safety and potential clinical benefit of noninvasive neurostimulation of the vagus nerve with the AlphaCore™ system for the relief of acute bronchoconstriction due to asthma.
Detailed description
The purpose of the study was to collect initial safety and efficacy information of use of the AlphaCore System by clinicians in an emergency setting as an adjunctive treatment to standard of care for the relief of acute bronchoconstriction. After consent was obtained and screening completed, subjects were stimulated two times, 30 minutes apart, for 90 seconds each. Subjects were assessed prior to and immediately post the first stimulation and at 15, 30, 60, and 90 minutes; follow was also conducted at day 7 and day 30.
Interventions
DEVICEAlphaCore System
Non-invasive neurostimulation of the vagus nerve
Sponsors
ElectroCore INC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Is between the ages of 18 and 70 years. 2. Has been admitted to an emergency care facility with a working diagnosis of bronchoconstriction due to asthma. 3. Has an FEV1\<60% predicted. 4. Is available and willing to return for an office visit at 7 days and participate in a 30-day telephone call from time of discharge from the ED. 5. Is able to give written Informed Consent, or his/her legally authorized representative is available to give written Informed Consent.
Exclusion criteria
1. Has a history of lung cancer, chronic obstructive pulmonary disease (COPD), or other co-morbidity due to irreversible narrowing of the airways. 2. Is at risk of imminent respiratory collapse: * Lung Function: FEV1 \< 25% predicted * Signs and symptoms of extreme respiratory distress at rest, such as accessory muscle use, chest retraction * Consciousness State: Drowsy, confused * Rapid deterioration in respiratory status (sudden change in respiratory rate, decrease in oxygen saturation, change in consciousness, etc). 3. Has an abscess or other infection or lesion (including lymphadenopathy) at the therapy head placement site. 4. Has known or suspected atherosclerotic cardiovascular disease, carotid artery disease (e.g. bruits or history of TIA or CVA) or congestive heart failure (CHF). 5. Has suspected or confirmed sepsis. 6. Has a clinically significant irregular heart rate or rhythm. 7. Clinically significant changes in blood pressure or is receiving pressors to maintain blood pressure. 8. Is currently implanted with an 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. 9. Has a history of carotid endarterectomy or vascular neck surgery on the right side. 10. Has been implanted with metal cervical spine hardware. 11. Has a condition that would interfere with VAS Dyspnea self-assessment. 12. Is pregnant. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 30 days | Subjects were assessed for adverse events for the duration of procedure. Subjects were also seen at 7 days and had a phone call at 30 days from the date of the stimulation procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Change in FEV1 (Forced Expiratory Volume at 1 Second) of 12% or More From Baseline to 30 Minutes | 30 minutes | Improvement in FEV1 was defined as an increase of at least 12% compared with baseline (pre-first stimulation). The 30 minute measure was taken immediately after the second stimulation. (FEV1 measured as a percentage of normal, where greater that 80% is normal and less than 40% is severe degree of obstruction.) |
| Improvement in Dyspnea Score of at Least 1.5 Points From Baseline to 30 Minutes | 30 minutes | Improvement in dyspnea was defined as at least 1.5 point decrease on a 10 point Visual Analogue Scale (VAS) compared with baseline (pre-first stimulation). Where 0 = no dyspnea and 10 = very severe dyspnea. The 30 minute measure was taken immediately after the second stimulation. |
| Time to Discharge From the Emergency Department | Duration of stay in emergency room - up to approximately 6 hours. | Time to discharge from the emergency department post stimulation |
| Number of Participants With Requirement for Concomitant Medications | Duration of stay in emergency room, up to approximately 6 hours | Requirement for concomitant medications. Medications administered in the emergency department pre and post stimulation |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AlphaCore System: Non-invasive Neurostimulation AlphaCore System: Non-invasive neurostimulation of the vagus nerve | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | AlphaCore System: Non-invasive Neurostimulation |
|---|---|
| Age, Continuous | 41 years |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized White | 5 Participants |
| Region of Enrollment South Africa | 6 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 1 / 6 |
| serious Total, serious adverse events | 1 / 6 |
Outcome results
Primary
Number of Participants With Adverse Events
Subjects were assessed for adverse events for the duration of procedure. Subjects were also seen at 7 days and had a phone call at 30 days from the date of the stimulation procedure.
Time frame: 30 days
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AlphaCore System: Non-invasive Neurostimulation | Number of Participants With Adverse Events | 2 Participants |
Secondary
Improvement in Dyspnea Score of at Least 1.5 Points From Baseline to 30 Minutes
Improvement in dyspnea was defined as at least 1.5 point decrease on a 10 point Visual Analogue Scale (VAS) compared with baseline (pre-first stimulation). Where 0 = no dyspnea and 10 = very severe dyspnea. The 30 minute measure was taken immediately after the second stimulation.
Time frame: 30 minutes
Population: Safety population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| AlphaCore System: Non-invasive Neurostimulation | Improvement in Dyspnea Score of at Least 1.5 Points From Baseline to 30 Minutes | Dyspnea score Pre-stimulation | 6.75 units on a scale |
| AlphaCore System: Non-invasive Neurostimulation | Improvement in Dyspnea Score of at Least 1.5 Points From Baseline to 30 Minutes | Dyspnea score at 30 minutes | 3.10 units on a scale |
Secondary
Number of Participants With a Change in FEV1 (Forced Expiratory Volume at 1 Second) of 12% or More From Baseline to 30 Minutes
Improvement in FEV1 was defined as an increase of at least 12% compared with baseline (pre-first stimulation). The 30 minute measure was taken immediately after the second stimulation. (FEV1 measured as a percentage of normal, where greater that 80% is normal and less than 40% is severe degree of obstruction.)
Time frame: 30 minutes
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AlphaCore System: Non-invasive Neurostimulation | Number of Participants With a Change in FEV1 (Forced Expiratory Volume at 1 Second) of 12% or More From Baseline to 30 Minutes | 4 Participants |
Secondary
Number of Participants With Requirement for Concomitant Medications
Requirement for concomitant medications. Medications administered in the emergency department pre and post stimulation
Time frame: Duration of stay in emergency room, up to approximately 6 hours
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AlphaCore System: Non-invasive Neurostimulation | Number of Participants With Requirement for Concomitant Medications | Pre stimulation medications | 5 Participants |
| AlphaCore System: Non-invasive Neurostimulation | Number of Participants With Requirement for Concomitant Medications | Post simulation medications | 6 Participants |
Secondary
Time to Discharge From the Emergency Department
Time to discharge from the emergency department post stimulation
Time frame: Duration of stay in emergency room - up to approximately 6 hours.
Population: Safety population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AlphaCore System: Non-invasive Neurostimulation | Time to Discharge From the Emergency Department | 193 minutes |