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

Not Applicable

Suspended

• Conditions: Gastroparesis
• Interventions: Device: Oculus Go VR headset; Device: Sham Oculus Go VR headset

• Registration Number: NCT05079568
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-10-02
• Study First Submitted QC: 2021-10-02
• Study First Posted: 2021-10-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-14
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active VR Group	Oculus Go VR headset	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.
Sham VR Group	Sham Oculus Go VR headset	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.

Primary Outcome Measures

Name	Time	Method
Patient-reported adverse events	4 weeks	Number of patient-reported adverse events assessed using standardized daily patient-reported adverse event questionnaires

Secondary Outcome Measures

Name	Time	Method
Changes in global gastroparesis symptom scores	Baseline, 4 weeks	Measured by the self-reported GCSI (Gastroparesis Cardinal Symptom Index-daily diary); consisting of questions about severity of symptoms experienced during the past 24 hours on a scale of none, mild, moderate, severe, and very severe.
Changes in gastrointestinal disorder symptoms	Baseline, 4 weeks	Measured using the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire; consisting of questions about severity of symptoms related to gastrointestinal problem during the past 2 weeks on a scale of 0=note to 5=very severe.
Changes in abdominal pain	Baseline, 4 weeks	Measured using a Numeric Pain Rating Scale (NRS) where subject place a X on a scale to show how much abdominal pain they had today; scale is 0% no abdominal pain, 100% worse abdominal pain ever.
Changes in individual scores for nausea	Baseline, 4 weeks	Measured using Visual Analogue Scale (VAS) where subject place a X on a scale to show how much nausea they had today; scale is 0%=no nausea, 100%=worse nausea ever.
Change in work productivity	Baseline, 4 weeks	Measured using the validated WPAI (work productivity activity index) to assess subject ability to work and perform regular activities
Change in Quality of life	Baseline, 4 weeks	Measured using the self-reported Short-Form 12 questionnaire; health survey to assess subject views about their health
Changes in bloating	Baseline, 4 weeks	Measured using the validated Mayo Bloating Questionnaire to assess subject symptoms of gastroparesis

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States