Last updated: January 24, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Gastroparesis
Treatment
Cognitive Behavioral Therapy
Clinical Study ID
NCT03531450
Partners Protocol ID Pending
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male and female patients aged 18 - 65 years old (inclusive)
- 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
- An idiopathic etiology
- 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.
- Body mass index (BMI) ≥ 17.5 kg/m2
- Have not previously received CBT for coping with chronic illness
- Have access to a computer with internet access
- Speak, write, and understand English
- On stable doses of any medication for 30 days prior to entering the study (exceptionsare psychotropic, opioids, and/or illicit drugs) and agrees not to change medicationsor dosages during the study period.
Exclusion
Exclusion Criteria:
- Inability to comply with or complete GES test (including allergy to eggs)
- Use of narcotic analgesics greater than three days per week
- Presence of other conditions that could explain the patient's symptoms:
- Pyloric or intestinal obstruction as determined by endoscopy, upper GI series orabdominal CT scan
- Active inflammatory bowel disease
- Known eosinophilic gastroenteritis or eosinophilic esophagitis
- Primary neurological conditions that could cause nausea and/or vomiting such asincreased intracranial pressure, space occupying or inflammatory/infectiouslesions
- Acute liver failure
- Acute renal failure
- Chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis orperitoneal dialysis
- Prior gastric surgery to restore function or relieve GI symptoms including totalor subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy,or gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy. Note: patientswith prior (Nissen, Dor, or Toupet) fundoplication will be eligible forenrollment.
- 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 withstudy requirements
- Inability to provide informed consent
- BMI more than 32 and/or weight > 235 lbs. (limits of the MRI table)
- Enteral or parenteral feeding
- Epilepsy or a prior history of seizures
- Pregnancy or nursing
- Psychotherapy initiated in the last 8 weeks
- Contraindications for MRI: High magnetic fields may pose a serious health hazard tosubjects with implanted ferromagnetic objects. Every subject in this study will becarefully screened before entering the high magnetic field shielded room to collect aprecise outline of the subject's medical history. Subjects with the followingcharacteristics/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 reportform, along with dosage information and start and stop dates. Patients requiring excludeddrugs will be discontinued from the study.
Study Design
Total Participants: 29
Treatment Group(s): 1
Primary Treatment: Cognitive Behavioral Therapy
Phase:
Study Start date:
December 07, 2018
Estimated Completion Date:
February 25, 2027
Study Description
Connect with a study center
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
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