A Study to Evaluate the Safety and Tolerability of Virtual Reality to Treat Gastroparesis

Trial details

Who runs it

Mayo Clinic

Trial code

NCT05079568

Record updated

6 March 2026

Original description

The purpose of this study is to determine if virtual reality therapy is safe and tolerable in treating gastroparesis.Read full original descriptionShow less

"A Pilot Study to Assess the Safety, Tolerability and Efficacy of Virtual Reality for the Treatment of Gastroparesis"

The purpose of this study is to determine if virtual reality therapy is safe and tolerable in treating gastroparesis.

Inclusion: Adult patients, men and women ages 18-75; Documented gastroparesis (idiopathic or diabetic); Patients who have had an upper endoscopy within the past 3 years not showing evidence of an organic disorder that could cause symptoms and a 4-hour scintigraphic gastric emptying scan showing evidence of delayed gastric emptying; Patients will be identified as direct referrals to the general GI clinic or the motility clinic, and will undergo screening history and physical examination by the PI or co-investigator.

Exclusion: Patients with prior surgery to the esophagus, stomach or duodenum; Patients whose symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease); If the patients have known uncontrolled diabetes (HgbA1c > 11), GERD, esophagitis, eosinophilic esophagitis, H. pylori, cannabinoid hyperemesis syndrome, celiac artery compression syndrome, or SMA syndrome; Alcohol and tobacco use will be assessed, as will the presence of psychiatric conditions, such as anxiety, depression, post-traumatic stress disorder, bipolar disorders, and eating disorders, such as anorexia nervosa and bulimia. However, no patient will be excluded based on reported substance use or presence of a psychiatric comorbidity, unless their psychological status represents potential harm to themselves, others, or represents an impediment to treatment; Patients with motion sickness, vertigo, or a seizure disorder will be excluded to prevent the theoretical risk of inducing or exacerbating symptoms related to the aforementioned conditions with VR; Patients taking opioids will also be excluded; Any patient identified as having a significant problem with alcohol or anxiety or depression will be referred back to their primary care provider for further evaluation and treatment.

ClinicalTrials.gov NCT05079568