Trial Outcomes & Findings for Noninvasive Neurostimulation of the Vagus Nerve for the Relief of Acute Bronchoconstriction Due to Asthma (NCT NCT01385306)

NCT ID: NCT01385306

Last Updated: 2018-11-09

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2018-11-09

Participant Flow

Participant milestones

Measure	AlphaCore System: Non-invasive Neurostimulation AlphaCore System: Non-invasive neurostimulation of the vagus nerve
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Noninvasive Neurostimulation of the Vagus Nerve for the Relief of Acute Bronchoconstriction Due to Asthma

Baseline characteristics by cohort

Measure	AlphaCore System: Non-invasive Neurostimulation n=6 Participants AlphaCore System: Non-invasive neurostimulation of the vagus nerve
Age, Continuous	41 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race/Ethnicity, Customized White	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Region of Enrollment South Africa	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Safety population

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.

Outcome measures

Measure	AlphaCore System: Non-invasive Neurostimulation n=6 Participants AlphaCore System: Non-invasive neurostimulation of the vagus nerve
Number of Participants With Adverse Events	2 Participants

SECONDARY outcome

Timeframe: 30 minutes

Population: Safety population

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.)

Outcome measures

Measure	AlphaCore System: Non-invasive Neurostimulation n=6 Participants AlphaCore System: Non-invasive neurostimulation of the vagus nerve
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 outcome

Timeframe: 30 minutes

Population: Safety population

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.

Outcome measures

Measure	AlphaCore System: Non-invasive Neurostimulation n=6 Participants AlphaCore System: Non-invasive neurostimulation of the vagus nerve
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 Interval 5.2 to 9.2
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 Interval 0.0 to 4.4

SECONDARY outcome

Timeframe: Duration of stay in emergency room - up to approximately 6 hours.

Population: Safety population.

Time to discharge from the emergency department post stimulation

Outcome measures

Measure	AlphaCore System: Non-invasive Neurostimulation n=6 Participants AlphaCore System: Non-invasive neurostimulation of the vagus nerve
Time to Discharge From the Emergency Department	193 minutes Interval 100.0 to 294.0

SECONDARY outcome

Timeframe: Duration of stay in emergency room, up to approximately 6 hours

Population: Safety population

Requirement for concomitant medications. Medications administered in the emergency department pre and post stimulation

Outcome measures

Measure	AlphaCore System: Non-invasive Neurostimulation n=6 Participants AlphaCore System: Non-invasive neurostimulation of the vagus nerve
Number of Participants With Requirement for Concomitant Medications Pre stimulation medications	5 Participants
Number of Participants With Requirement for Concomitant Medications Post simulation medications	6 Participants

Adverse Events

AlphaCore System: Non-invasive Neurostimulation

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	AlphaCore System: Non-invasive Neurostimulation n=6 participants at risk AlphaCore System: Non-invasive neurostimulation of the vagus nerve
Respiratory, thoracic and mediastinal disorders Hospitalization for respiratory tract infection	16.7% 1/6 • Number of events 1 • 30 days

Other adverse events

Measure	AlphaCore System: Non-invasive Neurostimulation n=6 participants at risk AlphaCore System: Non-invasive neurostimulation of the vagus nerve
Respiratory, thoracic and mediastinal disorders Chest tightness	16.7% 1/6 • Number of events 1 • 30 days

Additional Information

Clinical Affairs

electroCore LLC

Phone: +1 973 355 6683

Email: clinical@electrocorellc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60