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

Overview

Información sobre este estudio

We hypothesize that patients with gastroparesis (GP) who use regular sessions of active virtual reality (VR) will experience a greater reduction in global symptoms of gastroparesis, as measured by a reduction in symptom scores using the Gastroparesis Cardinal Symptom Index (GCSI), the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM), a visual analog scale for nausea (VAS) and a numerical rating scale for abdominal pain (NRS), compared to patients with GP treated with sham VR therapy. This pragmatic trial is a pilot study to assess the safety, tolerability and efficacy of virtual reality for the treatment of gastroparesis.

There are three main aims for this study. One, to determine whether VR is safe for the treatment of GP. Two, to determine whether using VR therapy is tolerable for the treatment of GP symptoms. Three, to determine whether VR is an effective treatment for symptoms of GP compared to sham VR therapy. A key objective of the third aim will be to compare changes in global gastroparesis symptom scores, as measured by the GCSI, at the end of the 4-week study period compared to baseline, in patients with GP treated with active VR therapy compared to those treated with sham VR. Secondary objectives for the third aim will be to assess changes in overall total PAGI-SYM scores, changes in individual scores for nausea (using a VAS), changes in abdominal pain using a NRS, and changes in bloating using the validated Mayo Bloating Questionnaire. Changes in work productivity will be assessed during the 4-week trial using the validated WPAI (work productivity activity index) while short-term changes in quality of life will be assessed using the Short-Form 12 questionnaire.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic	Estatus	Contacto
Jacksonville, Fla. Investigador principal de Mayo Clinic Brian Lacy, M.D., Ph.D.	Abierto para la inscripción	Contact information: Brian Lacy M.D., Ph.D. (904) 953-6970 Lacy.Brian@mayo.edu

Sede de Mayo Clinic

Estatus

Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Brian Lacy, M.D., Ph.D.

Abierto para la inscripción

Contact information:

Brian Lacy M.D., Ph.D.

(904) 953-6970

Lacy.Brian@mayo.edu

More information

Publicaciones

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