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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
6
Non-invasive neurostimulation of the vagus nerve
Kuilsriver Hospital
Kuils River, Cape Town, South Africa
Panorama Mediclinic
Panorama, Cape Town, South Africa
Life Vincent Pallotti Hospital
Pinelands, Cape Town, South Africa
Cape Gate Medi-Clinic Hospital
Stellenbosch, Cape Town, South Africa
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
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
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
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.
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
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Christiaan Barnard Memorial Hospital
Cape Town, South Africa