Patient Recruitment and Screening

Patients with DMGP were recruited from Dr McCallum’s Clinic and treatment programs at the Texas Tech University Health Science Center at El Paso. During the recruitment process, pre-qualified patients were presented with a study specific consent form. After being read by the patients, it was also explained by the patient based on the “tell-me-back” method, in order to completely secure the understanding of all tests and other relevant steps of the study.

Patients with documented DMGP were asked a standardized series of questions to determine whether they met criteria for participation with respect to age, prior medical history, and having been diagnosed with DMGP as well as having daily nausea present. Patients who qualified as eligible for participation were asked a further set of standardized questions about their ability to comply with the study protocol regarding EEG and EGG recordings, the use of the TEA, and sign a medical record release to allow verification of their medical history and DMGP diagnosis.

Inclusion criteria include: (1) males and females between ages 18–75 year old diagnosed with DMGP for at least 6 months; (2) symptomatic DMGP with nausea as a daily symptom with or without occasional vomiting; (3) at least 1 severe gastroparetic symptom or 2 moderate gastroparetic symptoms (see assessment of gastroparetic symptoms); (4) abnormal standard 4 hour scintigraphic gastric emptying results obtained in the past 2 years; (5) upper endoscopy or upper GI within the last year showing no evidence of obstruction or peptic ulcer; (6) no changes in patients clinical presentation which could require endoscopic testing; (7) subjects with high probability for compliance and completion of the study; and (8) average daily glucose level of < 275 mg/dL and > 75 mg/dL.

Exclusion criteria include: (1) uncontrolled diabetes with serum glucose greater than 300 mg/dL; (2) previous gastric surgeries eg, surgical resection of the stomach, evidence of small bowel obstruction, and gastric bypass surgery for obesity; (3) severe renal failure with hemodialysis; (4) active treatment for malignancy; (5) patients requiring frequent hospitalization for frequent vomiting; and (6) patients requiring narcotics for pain management.