NCT01923272

Non-Invasive Neurostimulation of the Vagus Nerve With the AlphaCore Device for the Relief of EIB

Non-Invasive Neurostimulation of the Vagus Nerve With the AlphaCore Device for the Relief of Exercised Induced Bronchoconstriction

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ElectroCore INC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled pilot study is to study feasibility and collect additional preliminary clinical data related to the safety and clinical benefits of non-invasive vagal nerve stimulation with the AlphaCore device for the treatment and prevention of exercise-induced bronchoconstriction, and to support the development and approval of a larger pivotal study. The objectives of this study are (1) to gather preliminary safety and efficacy data of the AlphaCore device for the treatment of EIB (Treatment Visit 1) and prevention of EIB (Treatment Visit 2), (2) to validate the sham device (blinding effects, placebo effect) as an effective control for use in future clinical studies, and (3) to support the development and approval of a pivotal study, confirm data collection methods and endpoint definitions, and confirm appropriateness of the subject follow up plan.

Detailed description

Study Design Summary Study Type: Prospective, randomized (allocated 1:1), double-blind, sham-controlled pilot study Sample Size: Up to 60 subjects Number of Sites: Up to 10 sites Anticipated Study Duration: 8 months Number of Study Visits: Three: 1. Screening Visit 2. Treatment Visit 1 - treatment with AlphaCore (active or sham) after exercise challenge 3. Treatment Visit 2 - Prophylactic treatment with AlphaCore (active or sham) prior to exercise challenge There will be a telephone follow-up call within 12-24 hours after the treatment visits occur as well as a 7-day (+/- 3 days) final phone call after Treatment Visit 2. \# of Study Arm(s): Two Arms 1. Active Treatment with the AlphaCore Device 2. Sham Treatment with an inactive sham device Blinding Double blind. The subject will be blinded to treatment assignment. Due to the treating Investigator's or designee designee's ability to detect differences in muscle effects between the active and sham device, the treating Investigator or designee cannot be blinded. Data assessors will be blinded.

Conditions

• Asthma

Interventions

Type	Name	Description
DEVICE	AlphaCore Device	Active stimulation to the vagal nerve
DEVICE	AlphaCore	Active AlphaCore treatment

Timeline

• Start date: 2012-10-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2013-08-15
• Last updated: 2013-08-15