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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3NS140971-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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Gastroparesis is a disorder characterized by delayed gastric emptying and symptoms including nausea, vomiting, and abdominal pain. Gastric electrical stimulation (GES) using the implanted Enterra™ neurostimulator is FDA-approved to treat nausea and vomiting but its impact on abdominal pain has not been well studied. This study evaluates whether alternative programming parameters of the Enterra™ device can reduce abdominal pain in patients with gastroparesis. Participants with an existing Enterra™ device will be randomized to one of three stimulation settings and followed for assessment of pain, gastrointestinal symptoms, quality of life, and medication use.
This is a multicenter, randomized, double-blind, active-controlled, three-arm parallel clinical trial in adults with gastroparesis who have an implanted Enterra™ gastric neurostimulator. All participants will complete a two-week run-in period using their baseline clinical device settings prior to randomization. Participants will then be randomly assigned in a 1:1:1 ratio to one of three gastric electrical stimulation parameter sets: standard nominal parameters (active control), special short-cycle parameters, or modified Enterra parameters delivered continuously. Participants will remain on their assigned blinded settings for eight weeks, during which validated patient-reported measures of abdominal pain, gastroparesis symptoms, quality of life, and pain medication use will be collected. After completion of blinded endpoint assessments, participants may select their preferred settings for an additional eight-week follow-up period. Optional substudy assessments include gastric function testing, inflammatory biomarker analysis, and autonomic nervous system testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nominal GES Parameters | Active Comparator | Continuous 24-hour gastric electrical stimulation using participants' standard clinically prescribed Enterra™ settings. |
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| Special Parameter GES | Experimental | Short-cycle stimulation (0.3 seconds on / 0.2 seconds off; 0.24 ms pulse width; 100 Hz frequency; 4-6 mA amplitude) delivered for one hour every eight hours, with nominal settings used during remaining time. |
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| Modified Enterra Parameters | Experimental | Continuous 24-hour stimulation (3 seconds on / 2 seconds off; 0.33 ms pulse width; 14 Hz frequency; 15-20 mA amplitude). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enterra™ neurostimulator | Device | Gastric Electrical Stimulation using implanted Enterra™ neurostimulator with protocol-specified programming parameters. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Abdominal Pain Score | Change from baseline in seven-day average of daily worst abdominal pain score measured using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst possible pain). | Baseline to 8 weeks after randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brief Pain Inventory Score | Change in Brief Pain Inventory (BPI) score from baseline to 8 weeks after randomization. The investigators will be using the Brief Pain Inventory (BPI) short form. The Brief Pain Inventory (BPI) scoring assesses pain severity and its interference with daily life using an 11-point numeric rating scale (0 = "no pain/interference", 10 = "worst pain/complete interference"). It provides two main scores: a Pain Severity Score (average of 4 items) and a Pain Interference Score (average of 7 items), where higher scores indicate greater impairment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas L Abell, MD | Contact | 502-588-4600 | thomas.abell@louisville.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville Clinical Trials Unit | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20420555 | Background | Gonzalez HC, Velanovich V. Enterra Therapy: gastric neurostimulator for gastroparesis. Expert Rev Med Devices. 2010 May;7(3):319-32. doi: 10.1586/erd.10.4. | |
| 10201478 | Background | Hoogerwerf WA, Pasricha PJ, Kalloo AN, Schuster MM. Pain: the overlooked symptom in gastroparesis. Am J Gastroenterol. 1999 Apr;94(4):1029-33. doi: 10.1111/j.1572-0241.1999.01008.x. |
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De-identified individual participant data will not be shared outside the investigative team.
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D059265 | Visceral Pain |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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Device programming assignments are coded and implemented by an independent unblinded technician. Participants and study personnel remain blinded during the randomized treatment phase.
| Baseline to 8 weeks after randomization. |
| Change in Gastroparesis Cardinal Symptom Index score | Change in Gastroparesis Cardinal Symptom Index (GCSI) score from baseline to 8 weeks after randomization. The Gastroparesis Cardinal Symptom Index (GCSI) is a patient-reported tool measuring the severity of gastroparesis symptoms over 2 weeks, assessing 9 items group into 3 subclasses: nausea/vomiting, fullness/early satiety, and bloating on a 0-5 scale. A total GCSI score ≥18 generally indicates moderate to severe symptoms, with lower scores indicating better symptom control. | From baseline to 8 weeks after randomization |
| Change in Pain Medications | Change in use of opioid and non-opioid pain medications during the 8-week randomized treatment period. | During the 8-week randomized treatment period. |
| Percent Reduction in Pain Score | Percent of responders defined as ≥30% reduction in pain score at 8 weeks. The investigators will be using the Brief Pain Inventory (BPI) short form. The Brief Pain Inventory (BPI) scoring assesses pain severity and its interference with daily life using an 11-point numeric rating scale (0 = "no pain/interference", 10 = "worst pain/complete interference"). It provides two main scores: a Pain Severity Score (average of 4 items) and a Pain Interference Score (average of 7 items), where higher scores indicate greater impairment. | Baseline to 8 weeks. |
| Change in Inflammatory Cytokines | Measured via serum testing including including IL-6, TNF-α, IL-1β, IL-8, and IFN-γ. | Baseline to 8 weeks. |
| Change in Autonomic Function | For measurements of autonomic function, participants will undergo traditional autonomic testing, an established technique that has been extensively applied. This testing is reported a two main components: Vagal Cholinergic, via RR variation with deep breathing and Valsalva Ratio as well as Sympathetic Adrenergic, via postural adjustment ratio and vasoconstriction to cold stress. The normal values for these are derived from extensive experience of nearly 3000 patients as well as normal controls. This testing is also performed with cutaneous electrograms, used as a combined autonomic enteric tool, for baseline, and response to cold and posture. | Baseline to 8 weeks |
| Change in Gastric Electrophysiology | Measured via electrogastrogram (EGG). The investigators will record mucosal and serosal measures at the time of placement of temporary GES electrodes, and before a temporary GES device is connected to the leads. The technique of mucosal electrogram recordings uses 2 leads, a proximal one in the upper gastric body and a distal one near the body antral junction, which allows for low resolution mapping of the stomach. The recordings will be analyzed by signal averaging and reported as frequency, amplitude and their ratio. All patients will also have baseline cutaneous electrograms as well, for reference, analyzed in a similar manner. | baseline to 8 weeks |
| 20003077 | Background | Parkman HP, Camilleri M, Farrugia G, McCallum RW, Bharucha AE, Mayer EA, Tack JF, Spiller R, Horowitz M, Vinik AI, Galligan JJ, Pasricha PJ, Kuo B, Szarka LA, Marciani L, Jones K, Parrish CR, Sandroni P, Abell T, Ordog T, Hasler W, Koch KL, Sanders K, Norton NJ, Hamilton F. Gastroparesis and functional dyspepsia: excerpts from the AGA/ANMS meeting. Neurogastroenterol Motil. 2010 Feb;22(2):113-33. doi: 10.1111/j.1365-2982.2009.01434.x. Epub 2009 Dec 9. |
| 33548234 | Background | Pasricha PJ, Grover M, Yates KP, Abell TL, Bernard CE, Koch KL, McCallum RW, Sarosiek I, Kuo B, Bulat R, Chen J, Shulman RJ, Lee L, Tonascia J, Miriel LA, Hamilton F, Farrugia G, Parkman HP; National Institute of Diabetes and Digestive and Kidney Diseases/National Institutes of Health Gastroparesis Clinical Research Consortium. Functional Dyspepsia and Gastroparesis in Tertiary Care are Interchangeable Syndromes With Common Clinical and Pathologic Features. Gastroenterology. 2021 May;160(6):2006-2017. doi: 10.1053/j.gastro.2021.01.230. Epub 2021 Feb 3. |
| 23414452 | Background | Hasler WL, Wilson LA, Parkman HP, Koch KL, Abell TL, Nguyen L, Pasricha PJ, Snape WJ, McCallum RW, Sarosiek I, Farrugia G, Calles J, Lee L, Tonascia J, Unalp-Arida A, Hamilton F. Factors related to abdominal pain in gastroparesis: contrast to patients with predominant nausea and vomiting. Neurogastroenterol Motil. 2013 May;25(5):427-38, e300-1. doi: 10.1111/nmo.12091. Epub 2013 Feb 17. |
| 30734412 | Background | Revicki DA, Speck RM, Lavoie S, Puelles J, Kuo B, Camilleri M, Almansa C, Parkman HP. The American neurogastroenterology and motility society gastroparesis cardinal symptom index-daily diary (ANMS GCSI-DD): Psychometric evaluation in patients with idiopathic or diabetic gastroparesis. Neurogastroenterol Motil. 2019 Apr;31(4):e13553. doi: 10.1111/nmo.13553. Epub 2019 Feb 7. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D059226 | Nociceptive Pain |
| D010146 | Pain |