A Randomized, Single Centre, Double-blind, Parallel, Sham-controlled Pilot Study Using gammaCore®-G

ElectroCore

Status: Completed

Conditions: Irritable Bowel Syndrome; Dyspepsia

Treatments: Device: gammaCore®-G

Study type: Interventional

Funder types: Industry

Identifiers

NCT02388269

GG-007

Details and patient eligibility

About

A randomized, sham-controlled, single-centre pilot investigation designed to compare two parallel groups, gammaCore®-G (active treatment) and a sham, (inactive) treatment in subjects with FGIDs.

Full description

This study, in subjects with FGIDs, is a , randomized, sham-controlled, single-centre pilot investigation designed to compare two parallel groups, gammaCore®-G (active treatment) and a sham, (inactive) treatment. The study period will begin with a two-week run-in period, followed by a four week comparative period when the subjects will randomized (1:1) to either active treatment or sham (inactive) treatment. The comparative period will be followed by an open label four week period, where the subjects in the sham treatment group will switch in treatment assignment to receive active treatment and the active group will continue to receive an active treatment.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The subjects have to meet all of the following criteria to be eligible to enter the investigation:

1. Signed Informed Consent Form

2. Age >18

3. Diagnose with FD or IB Rome III criteria

4. Is able to complete the diary, use the device and to follow study procedures

5. Dyspepsia inclusion criteria, functional dyspepsia according to Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders, one or more of the following:

   • Bothersome postprandial fullness
   • Early satiation
   • Epigastric pain
   • Epigastric burning
   • No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms * Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis

6. IBS inclusion criteria, Irritable Bowel Syndrome* according to Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders

7. Recurrent abdominal pain or discomfort** at least 3 days/month in the previous 3 months associated with two or more of the following:

   • Improvement with defecation
   • Onset associated with a change in frequency of stool
   • Onset associated with a change in form (appearance) of stool
   • Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis ** "Discomfort" means an uncomfortable sensation not described as pain.

8. In pathophysiology research and clinical trials, a pain/discomfort frequency of at least 2 days a week during screening evaluation is recommended for subject eligibility.

Exclusion criteria

Subjects meeting any of the following criteria will not be permitted to enter the investigation:

1. Any positive endoscopic findings such as abnormal biopsy findings and/or any other abnormal finding judged by the Investigator
2. Any positive findings after sigmoidoscopy or colonoscopy such as diverticulosis, inflammatory bowel disease or other abnormal finding judged by the Investigator.
3. Vagotomy at any location
4. Has a neck lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the site gammaCore®-G treatment
5. Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of transient ischemic attack (TIA) or cerebral vascular accident CVA), congestive heart failure (CHF), known severe coronary artery disease or recent (5 years) myocardial infarction
6. Has an abnormal baseline ECG (e.g. second and third degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction
7. Has uncontrolled hypertension
8. Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, gastric stimulator or cochlear implant
9. Has a history of carotid endarterectomy or vascular neck surgery
10. Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore®-G stimulation site
11. Has a recent (within 12 months) or repeated history of syncope
12. Has a recent (within 12 months) or repeated history of seizures
13. Has psychiatric or cognitive disorder and/or behavioural problems which in the opinion of the clinician may interfere with the study
14. Is pregnant, nursing, thinking of becoming pregnant during the study period
15. Is participating in any other therapeutic clinical investigation or has participated in a clinical trial within 30 days period prior to this study
16. Is a relative of or an employee of the investigator or the clinical study site
17. Used gammaCore®-G previously

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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91 participants in 2 patient groups

gammaCore®-G

Active Comparator group

Description:

The user/operator applies the gammaCore®-G device to the skin on the right side and left side of the neck. The 2 stimulations should be performed on the same side of the neck before stimulating the other side. This is also applies with the doses increase in the open label phase. The user applies conductive gel to the stimulation surfaces to maintain an uninterrupted conductive path from the stimulation surfaces to the skin. The device is capable of delivering multiple patient treatments (doses). Each dose consists of 90 seconds of stimulation; for each dose, the device is active for 120 seconds before automatically stopping stimulation.The extra 30 seconds allows .

Treatment:

Device: gammaCore®-G

gammaCore®-G sham

Sham Comparator group

Description:

The sham device is a hand-held portable device that appears identical to the gammaCore®-G, in look, weight, visual and audible feedback, user application and control. It passes a low frequency (0.1 Hz) biphasic DC signal into the tissue, which can be felt as a tingling sensation but does not stimulate the vagus nerve or cause muscle contraction. Similar to the active device, the sensation becomes more pronounced as the amplitude is increased, until it is uncomfortable, at which point the amplitude is decreased slightly until tolerable. Like the active device, the sham device is a multi-use device capable programmed to deliver up to 150, 90-second "treatments" with a 30-second margin for set-up and operator adjustment of the "stimulation intensity".

Treatment:

Device: gammaCore®-G