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

Gastroparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05079568
• Other study ID #: 21-007072
• Status: Suspended
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Device:
• Oculus Go VR headset
Virtual reality programs consisting of interactive games, meditation and deep breathing exercises, and passive virtual reality experiences designed to facilitate relaxation.
• Sham Oculus Go VR headset
Virtual reality program with two-dimensional nature video

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported adverse events	Number of patient-reported adverse events assessed using standardized daily patient-reported adverse event questionnaires	4 weeks
Secondary	Changes in global gastroparesis symptom scores	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.	Baseline, 4 weeks
Secondary	Changes in gastrointestinal disorder symptoms	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.	Baseline, 4 weeks
Secondary	Changes in individual scores for nausea	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.	Baseline, 4 weeks
Secondary	Changes in abdominal pain	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.	Baseline, 4 weeks
Secondary	Changes in bloating	Measured using the validated Mayo Bloating Questionnaire to assess subject symptoms of gastroparesis	Baseline, 4 weeks
Secondary	Change in work productivity	Measured using the validated WPAI (work productivity activity index) to assess subject ability to work and perform regular activities	Baseline, 4 weeks
Secondary	Change in Quality of life	Measured using the self-reported Short-Form 12 questionnaire; health survey to assess subject views about their health	Baseline, 4 weeks

External Links

•   Mayo Clinic Clinical Trials