Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
ElectroCore INC
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.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
