Clinical trial NCT05079568: A Study to Evaluate the Safety and Tolerability of Virtual Reality to Treat Gastroparesis
Official title: "A Pilot Study to Assess the Safety, Tolerability and Efficacy of Virtual Reality for the Treatment of Gastroparesis"
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Gastroparesis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient-reported adverse events
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in global gastroparesis symptom scores
timeFrame: Baseline, 4 weeks
measure: Changes in gastrointestinal disorder symptoms
timeFrame: Baseline, 4 weeks
measure: Changes in individual scores for nausea
timeFrame: Baseline, 4 weeks
measure: Changes in abdominal pain
timeFrame: Baseline, 4 weeks
measure: Changes in bloating
timeFrame: Baseline, 4 weeks
measure: Change in work productivity
timeFrame: Baseline, 4 weeks
measure: Change in Quality of life
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Brian Lacy, MD
role: PRINCIPAL_INVESTIGATOR
References: