Back to resultsA Study to Evaluate the Safety and Tolerability of Virtual Reality to Treat Gastroparesis
Primary Purpose
Gastroparesis
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oculus Go VR headset
Sham Oculus Go VR headset
Sponsored by
About this trial
This is an interventional treatment trial for Gastroparesis
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.
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active VR Group
Sham VR Group
Arm 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.
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.
Outcomes
Primary Outcome Measures
Patient-reported adverse events
Number of patient-reported adverse events assessed using standardized daily patient-reported adverse event questionnaires
Secondary Outcome Measures
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.
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.
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.
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.
Changes in bloating
Measured using the validated Mayo Bloating Questionnaire to assess subject symptoms of gastroparesis
Change in work productivity
Measured using the validated WPAI (work productivity activity index) to assess subject ability to work and perform regular activities
Change in Quality of life
Measured using the self-reported Short-Form 12 questionnaire; health survey to assess subject views about their health
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05079568
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Suspended
Why Stopped
Pending funding
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blind, randomized.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active VR Group
Arm Type
Experimental
Arm 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.
Arm Title
Sham VR Group
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Oculus Go VR headset
Intervention Description
Virtual reality programs consisting of interactive games, meditation and deep breathing exercises, and passive virtual reality experiences designed to facilitate relaxation.
Intervention Type
Device
Intervention Name(s)
Sham Oculus Go VR headset
Intervention Description
Virtual reality program with two-dimensional nature video
Primary Outcome Measure Information:
Title
Patient-reported adverse events
Description
Number of patient-reported adverse events assessed using standardized daily patient-reported adverse event questionnaires
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Changes in global gastroparesis symptom scores
Description
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.
Time Frame
Baseline, 4 weeks
Title
Changes in gastrointestinal disorder symptoms
Description
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.
Time Frame
Baseline, 4 weeks
Title
Changes in individual scores for nausea
Description
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.
Time Frame
Baseline, 4 weeks
Title
Changes in abdominal pain
Description
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.
Time Frame
Baseline, 4 weeks
Title
Changes in bloating
Description
Measured using the validated Mayo Bloating Questionnaire to assess subject symptoms of gastroparesis
Time Frame
Baseline, 4 weeks
Title
Change in work productivity
Description
Measured using the validated WPAI (work productivity activity index) to assess subject ability to work and perform regular activities
Time Frame
Baseline, 4 weeks
Title
Change in Quality of life
Description
Measured using the self-reported Short-Form 12 questionnaire; health survey to assess subject views about their health
Time Frame
Baseline, 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Lacy, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
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A Study to Evaluate the Safety and Tolerability of Virtual Reality to Treat Gastroparesis
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