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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05079568
Recruitment Status : Recruiting
First Posted : October 15, 2021
Last Update Posted : December 21, 2021
Sponsor:
Information provided by (Responsible Party):
Brian E. Lacy, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Gastroparesis Device: Oculus Go VR headset Device: Sham Oculus Go VR headset Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double blind, randomized.
Primary Purpose: Treatment
Official Title: "A Pilot Study to Assess the Safety, Tolerability and Efficacy of Virtual Reality for the Treatment of Gastroparesis"
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active VR Group
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.
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 Comparator: Sham VR Group
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.
Device: Sham Oculus Go VR headset
Virtual reality program with two-dimensional nature video




Primary Outcome Measures :
  1. Patient-reported adverse events [ Time Frame: 4 weeks ]
    Number of patient-reported adverse events assessed using standardized daily patient-reported adverse event questionnaires


Secondary Outcome Measures :
  1. Changes in global gastroparesis symptom scores [ Time Frame: 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.

  2. Changes in gastrointestinal disorder symptoms [ Time Frame: 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.

  3. Changes in individual scores for nausea [ Time Frame: 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.

  4. Changes in abdominal pain [ Time Frame: 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.

  5. Changes in bloating [ Time Frame: Baseline, 4 weeks ]
    Measured using the validated Mayo Bloating Questionnaire to assess subject symptoms of gastroparesis

  6. Change in work productivity [ Time Frame: Baseline, 4 weeks ]
    Measured using the validated WPAI (work productivity activity index) to assess subject ability to work and perform regular activities

  7. Change in Quality of life [ Time Frame: Baseline, 4 weeks ]
    Measured using the self-reported Short-Form 12 questionnaire; health survey to assess subject views about their health



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05079568


Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: brian lacy, phd, md    904-650-2000    lacy.brian@mayo.edu   
Principal Investigator: Brian Lacy, MD         
Sub-Investigator: David Cnagemi, MD         
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Brian Lacy, phd, md    904-650-2000    lacy.brian@mayo.edu   
Contact: david cangemi, md         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Brian Lacy, MD Mayo Clinic
Additional Information:
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Responsible Party: Brian E. Lacy, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT05079568    
Other Study ID Numbers: 21-007072
First Posted: October 15, 2021    Key Record Dates
Last Update Posted: December 21, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations