Economic impact of gammaCore® -R nNVS in multifunctional disorders
Research type
Research Study
Full title
GC-13: An open label study investigating the economic impact of using non-invasive vagus nerve stimulation (nVNS) for the treatment of multi-symptomatic patients with functional disorders.
IRAS ID
167463
Contact email
Sponsor organisation
electroCore LLC
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
An open label study investigating the economic impact of using Non-invasive Vagus Nerve Stimulation (nVNS), using the gammacore®-R device, for the treatment of patients with more than one functional disorder (medical condition that impairs the normal function of a bodily process) . The subject’s average annual healthcare utilization cost for treatment of their functional disorders (total cost of hospital referrals, primary care consultations and prescription items) will be calculated based on three years retrospective data. This retrospective annual average will be compared against 12-months prospective healthcare utilization data from the 12 month study period in which the patient receives gammaCore treatment. Up to 625 subjects in total in the UK will be enrolled from 7 General Practices (study sites).
Participating subjects will have one condition (primary presenting condition) from the following list of conditions for which the therapy is currently approved (migraine, irritable bowel syndrome, functional dyspepsia, anxiety and depression) and also a second condition (secondary presenting condition) identified from a list of conditions including the conditions for which the treatment is approved (migraine, irritable bowel syndrome, functional dyspepsia, anxiety and depression) and also including the following conditions for which the treatment is not approved: insomnia, chronic sinusitis and fibromyalgia.
In addition to studying the economic impact, the study will also compare the change in frequency and perceived symptom severity of subjects’ primary and secondary conditions at 6 and 12 months after using nVNS therapy, these will be assessed using validated disease/symptom questionnaires/scales and also quality of life using the EQ-5D-5L scale.
The study includes a ‘run-in’ and a ‘treatment’ period. The run-in will last 1 week, during which the subject be given the gammaCore device, and will familiarize themselves with the device and also study diary. During the 12 month treatment period subjects will record their treatment compliance and medications and any adverse events in their electronic study diaries.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
15/SW/0108
Date of REC Opinion
8 May 2015
REC opinion
Unfavourable Opinion