Trial Outcomes & Findings for Neurostimulation for the Relief of Acute Bronchoconstriction (NCT NCT00762931)

NCT ID: NCT00762931

Last Updated: 2018-05-15

Results Overview

Safety- Number of participants that reported Adverse Events

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2018-05-15

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	25
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neurostimulation for the Relief of Acute Bronchoconstriction

Baseline characteristics by cohort

Measure	Resolve Stimulator and Proximity Lead n=25 Participants 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
Age, Continuous	41 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race/Ethnicity, Customized Black	18 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic and white	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic Latino	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic Black	1 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Safety

Safety- Number of participants that reported Adverse Events

Outcome measures

Measure	Resolve Stimulator and Proximity Lead n=25 Participants 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
Safety- Number of Participants With Adverse Events	16 Participants

SECONDARY outcome

Timeframe: 60 minutes

Population: Safety population. 1 subject result missing due to no stimulation performed.

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%.

Outcome measures

Measure	Resolve Stimulator and Proximity Lead n=24 Participants 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
Improvement of Common Measures of Breathing Performance, Forced Expiry Volume in 1second (FEV1).	19 Participants

Adverse Events

Resolve Stimulator and Proximity Lead

Serious events: 11 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Measure	Resolve Stimulator and Proximity Lead n=25 participants at risk 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
Respiratory, thoracic and mediastinal disorders Hospitalization for chest pain associated with cocaine use	4.0% 1/25 • Number of events 1 • 2 weeks
Respiratory, thoracic and mediastinal disorders Hospitalization for asthma exacerbation	16.0% 4/25 • Number of events 4 • 2 weeks
Respiratory, thoracic and mediastinal disorders Hospitalization for persistant asthma symptoms	8.0% 2/25 • Number of events 2 • 2 weeks
Respiratory, thoracic and mediastinal disorders Death at 15 days post treatment	4.0% 1/25 • Number of events 1 • 2 weeks
Respiratory, thoracic and mediastinal disorders Hospitalization for observation; respiratory	4.0% 1/25 • Number of events 1 • 2 weeks
Respiratory, thoracic and mediastinal disorders Hospitalization for pneumonia	4.0% 1/25 • Number of events 1 • 2 weeks
Reproductive system and breast disorders Hospitalization for continuation of asthma exacerbation	4.0% 1/25 • Number of events 1 • 2 weeks

Other adverse events

Measure	Resolve Stimulator and Proximity Lead n=25 participants at risk 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
Musculoskeletal and connective tissue disorders Muscle twitching in neck	12.0% 3/25 • Number of events 4 • 2 weeks
Endocrine disorders Sweating during attempted lead advancement	4.0% 1/25 • Number of events 1 • 2 weeks
Surgical and medical procedures Lead displacement	4.0% 1/25 • Number of events 1 • 2 weeks
Musculoskeletal and connective tissue disorders Neck pain for 2 days post treatment	4.0% 1/25 • Number of events 1 • 2 weeks
Vascular disorders Hematoma	4.0% 1/25 • Number of events 1 • 2 weeks
Vascular disorders Bleeding at insertion site	4.0% 1/25 • Number of events 1 • 2 weeks
Respiratory, thoracic and mediastinal disorders Asthma exacerbation	4.0% 1/25 • Number of events 1 • 2 weeks

Additional Information

Clinical Affairs electroCore LLC

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