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

Mayo Clinic

Status: Suspended

Conditions: Gastroparesis

Treatments: Device: Sham Oculus Go VR headset; Device: Oculus Go VR headset

Study type: Interventional

Funder types: Other

Identifiers

NCT05079568

21-007072

Details and patient eligibility

About

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

Full description

After informed consent patients will be randomized to a 4 week treatment program comparing active VR treatment to sham VR treatment. Symptoms will be measured at baseline and at 2 and 4 weeks using validated questionnaires. A short questionnaire will be answered daily to evaluate changes in nausea.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.
• Patients with prior surgery to the esophagus, stomach or duodenum.
• Patients taking opioids will also be excluded.
• 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.
• 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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Active VR Group

Experimental group

Description:

Subjects will be provided an Oculus Go VR headset pre-loaded with a "menu" of virtual reality programs which have been designed specifically to treat both acute and chronic pain. Subjects are required to use the VR headset at home four times daily, prior to breakfast, lunch, dinner, and bedtime. Each session will last approximately 15 minutes.

Treatment:

Device: Oculus Go VR headset

Sham VR Group

Sham Comparator group

Description:

Subjects will be provided an Oculus Go VR headset pre-loaded two-dimensional nature video. Subjects are required to use the VR headset at home four times daily, prior to breakfast, lunch, dinner, and bedtime. Each session will last approximately 15 minutes.

Treatment:

Device: Sham Oculus Go VR headset