Study of Enterra Programming With Nocturnal Cycling in Gastroparetics (RESTING)
Gastroparesis, Gastroparesis Nondiabetic, Gastroparesis Due to Diabetes Mellitus
About this trial
This is an interventional treatment trial for Gastroparesis focused on measuring Gastric electrical stimulation, Gastroparesis
Eligibility Criteria
In order to be eligible to participate in this study, a participant must meet all of the following criteria: Completed informed consent process with signed and dated informed consent form; Stated willingness to comply with all study procedures and availability for the duration of the study; Male or female, aged ≥18 or ≤70 at time of informed consent; Currently implanted with the Enterra™ Therapy System (Enterra™ II 37800 neurostimulator); High GES output defined as remaining pulse generator expected life of > 9 months from enrollment and less than 4 years from the time of implant; Stable gastroparesis symptoms, in the opinion of the investigator; On stable medical therapy for gastroparesis symptoms; On stable supplemental nutritional support during the month prior to enrollment. A participant who meets any of the following criteria will be excluded from participation in this study: Post-surgical gastroparesis (e.g., fundoplication, Bilroth I or II) or other active stomach or gastrointestinal diseases disorders which could explain symptoms in the opinion of the investigator; Subjects, in the opinion of the investigator, with profound nausea and/or vomiting at night; Subjects, in the opinion of the investigator, with profound gastroparesis symptoms upon waking in the morning; Subjects without a regular and defined sleep schedule; Pregnancy, or subject that intends to become pregnant during participation in the study; Chemical dependency; Enterra lead impedance measurements ≥ 700 Ohms at screening visit; Life expectancy < 1 year from conditions other than GI diseases; Subjects with an underlying disease leading to follow-up by MRI; Participation in other clinical studies; Subjects involved in current or past medical-related litigation; Subjects with cognitive impairment or other characteristic that would limit subject's ability to complete study requirements.
Sites / Locations
- University of LouisvilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Control Sleep Cycle
Arm 1 Sleep Cycle
Arm 2 Sleep Cycle
Baseline device programming parameters will be used during study participation. No modification to Enterra™ device programming will be in effect during waking or sleeping hours.
Device programming parameters participants have at enrollment will be used during waking hours. During sleeping hours, the Enterra™ device will cycle through modified programming over the course of 6 hours. Each hour, the Enterra™ device will deliver 30 minutes of reduced stimulation, followed by 30 minutes of waking hours stimulation. At the end of the 6-hour sleep cycle, the Enterra™ device will return to waking hours programming.
Device programming parameters participants have at enrollment will be used during waking hours. During sleeping hours, the Enterra™ device will cycle through modified programming over the course of 8 hours. Each hour, the Enterra™ device will deliver 45 minutes of reduced stimulation, followed by 15 minutes of waking hours stimulation. At the end of the 8-hour sleep cycle, the Enterra™ device will return to waking hours programming.