Gastrointestinal Myoelectric Activity Protocol, the G-Tech EEnG Protocol

This single-arm, non-randomized feasibility study has been designed to transcutaneously
detect and monitor myoelectric intestinal signals temporally associated with the symptoms of
patients who report pain and have suspected or diagnosed IBS, and in controls [subjects
without suspected IBS or diagnosis of IBS and prior and/or current complaints of pain].

General Eligibility Criteria:

General Inclusion Criteria

- Willing and able to provide informed consent;

- Eighteen (18) years of age or older;

- Willing and able to follow a specified study procedure regimen;

- No known allergy to commercially available food or drink required by specified study
procedure regimen;

- Willing and able to recline and remain still during the recordings.

General Exclusion Criteria

- Subject has an implantable device such as a pacemaker, defibrillator, nerve
stimulator, insulin pump, automatic analgesic pump, or other automated implanted
medical device;

- Known allergy to isopropyl (rubbing) alcohol;

- Known allergy to Ag/AgCl electrodes;

- Known allergy to glue adhesive (electrode adhesive);

- Dietary restrictions not permitting intake of food or drink required by this protocol;

- Dietary restrictions not permitting four (4) hour fasting period prior to start of
myoelectric recording;

- Subject is pregnant or suspects pregnancy;

- Open sores or wounds on the abdomen;

- Any injury in or around the area of electrode placement that would cause pain with
gentle pressure required for electrode and lead wire placement;

- Weight > 300 lbs (136 Kg) (excess weight can interfere with quality of the signals).

IBS With Complaints of GI Pain Eligibility Criteria IBS With Complaints of Pain Inclusion
Criteria All answers must be "YES" to the All of the Following Inclusion Criteria Prior
diagnosis of IBS and complaints of GI pain IBS With Complaints of Pain Exclusion Criteria
All answers must be "NO" to the All of the Following Exclusion Criteria Functional
dyspepsia; No reports of GI pain, past or present.

Control Subjects Eligibility Criteria Subjects who do NOT have a prior diagnosis of
functional GI disorder

Control Subjects Inclusion Criteria All answers must be "YES" to the All of the Following
Inclusion Criteria

No prior diagnosis IBS; No complaints of GI pain.

Control Subjects Exclusion Criteria All answers must be "NO" to the All of the Following
Exclusion Criteria Current diagnosis of any GI disorder; Current or recent complaints of GI
pain.