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

NCT ID: NCT02388269

Last Updated: 2018-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-06-30

Brief Summary

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.

Detailed 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.

Conditions

Dyspepsia; Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

gammaCore®-G

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 .

Group Type: ACTIVE_COMPARATOR

gammaCore®-G

Intervention Type: DEVICE

The gammaCore®-G device is a reusable, hand-held, portable device consisting of two 3.0 VDC batteries (not replaceable or user serviceable), signal generating and amplifying electronics, and two buttons for operator control of the signal amplitude. The device provides visible (light display) and audible feedback on device and stimulation status

gammaCore®-G sham

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".

Group Type: SHAM_COMPARATOR

gammaCore®-G

Intervention Type: DEVICE

The gammaCore®-G device is a reusable, hand-held, portable device consisting of two 3.0 VDC batteries (not replaceable or user serviceable), signal generating and amplifying electronics, and two buttons for operator control of the signal amplitude. The device provides visible (light display) and audible feedback on device and stimulation status

Interventions

gammaCore®-G

The gammaCore®-G device is a reusable, hand-held, portable device consisting of two 3.0 VDC batteries (not replaceable or user serviceable), signal generating and amplifying electronics, and two buttons for operator control of the signal amplitude. The device provides visible (light display) and audible feedback on device and stimulation status

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ElectroCore INC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Owen Epstein, Prof.

Role: PRINCIPAL_INVESTIGATOR

Royal Free Hospital NHS Foundation Trust

Locations

Royal Free Hospital NHS Trust, Centre for Gastroenterology, 8th floor, Pond street

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

GG-007

Identifier Type: -

Identifier Source: org_study_id