Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT03531450
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients aged 18 - 65 years old (inclusive)
2. Symptoms of gastroparesis of at least 12 weeks duration (do not have to be continuous) with varying degrees of nausea, vomiting, early satiety, and/or post-prandial fullness
3. An idiopathic etiology
4. GES of solids using 4 hours Egg Beaters® protocol within the last 2 years with either:
\- Abnormal gastric emptying rate defined as an abnormal 2 hour (\>60% retention) and/or 4 hour (\>10% retention) result based on a 4 hour scintigraphic low fat Egg Beaters® gastric emptying study.
5. Body mass index (BMI) ≥ 17.5 kg/m2
6. Have not previously received CBT for coping with chronic illness
7. Have access to a computer with internet access
8. Speak, write, and understand English
9. On stable doses of any medication for 30 days prior to entering the study (exceptions are psychotropic, opioids, and/or illicit drugs) and agrees not to change medications or dosages during the study period.
Exclusion Criteria:
1. Inability to comply with or complete GES test (including allergy to eggs)
2. Use of narcotic analgesics greater than three days per week
3. Presence of other conditions that could explain the patient's symptoms:
* Pyloric or intestinal obstruction as determined by endoscopy, upper GI series or abdominal CT scan
* Active inflammatory bowel disease
* Known eosinophilic gastroenteritis or eosinophilic esophagitis
* Primary neurological conditions that could cause nausea and/or vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
* Acute liver failure
* Acute renal failure
* Chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis
* Prior gastric surgery to restore function or relieve GI symptoms including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, or gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy. Note: patients with prior (Nissen, Dor, or Toupet) fundoplication will be eligible for enrollment.
* Subject has current evidence of duodenal ulcer, gastric ulcer, diverticulitis, active GERD or infectious gastroenteritis.
* Any acute gastrointestinal process.
* Any other plausible structural or metabolic cause
* Any condition, which in the opinion of the investigator, would interfere with study requirements
4. Inability to provide informed consent
5. BMI more than 32 and/or weight \> 235 lbs. (limits of the MRI table)
6. Enteral or parenteral feeding
7. Epilepsy or a prior history of seizures
8. Pregnancy or nursing
9. Psychotherapy initiated in the last 8 weeks
10. Contraindications for MRI: High magnetic fields may pose a serious health hazard to subjects with implanted ferromagnetic objects. Every subject in this study will be carefully screened before entering the high magnetic field shielded room to collect a precise outline of the subject's medical history. Subjects with the following characteristics/disease will not be eligible to participate in the study:
* History of Head Trauma
* Any metallic implants (e.g. braces or permanent retainers)
* Tattoos with metallic ink above the nipple line
* Surgical Aneurysm Clips
* Cardiac Pacemaker
* Prosthetic Heart Valve
* Neurostimulator
* Implanted pumps
* Cochlear Implants
* Metal rods, Plates
* Screws
* Recent Previous Surgery
* IUD
* Hearing Aid
* Dentures (which might create NMR artifacts)
* Metal Injury to eyes
* Pregnancy or plans to become pregnant
* Breast Feeding
* Meniere's Disease
* Transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop, or Ortho Evra (birth control)
* Claustrophobia
* Suicidal ideation as indicated from the HADS
All concomitant medications taken during the study will be recorded in the case report form, along with dosage information and start and stop dates. Patients requiring excluded drugs will be discontinued from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03531450
Study Brief:
Protocol Section:
NCT03531450