Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis

Overview

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.

Detailed description

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.

Interventions

• Device Enterra™ neurostimulator
  Gastric Electrical Stimulation using implanted Enterra™ neurostimulator with protocol-specified programming parameters.

Primary outcome measures

• Change in Abdominal Pain Score [Time frame: Baseline to 8 weeks after randomization.]

Secondary outcome measures (7)

• Change in Brief Pain Inventory Score [Time frame: Baseline to 8 weeks after randomization.]
• Change in Gastroparesis Cardinal Symptom Index score [Time frame: From baseline to 8 weeks after randomization]
• Change in Pain Medications [Time frame: During the 8-week randomized treatment period.]
• Percent Reduction in Pain Score [Time frame: Baseline to 8 weeks.]
• Change in Inflammatory Cytokines [Time frame: Baseline to 8 weeks.]
• Change in Autonomic Function [Time frame: Baseline to 8 weeks]
• Change in Gastric Electrophysiology [Time frame: baseline to 8 weeks]

Eligibility criteria

Inclusion criteria

• Adults aged 18 years or older.
• Diagnosed gastroparesis.
• Implanted Enterra™ device for at least 8 weeks prior to enrollment.
• Chronic daily abdominal pain of gastric origin lasting more than 2 months.
• Average pain score ≥4 on a 0-10 scale.
• Ability to provide informed consent.

Exclusion criteria

• Daily opioid use.
• Pregnancy or breastfeeding.
• Abdominal pain not attributed to gastric/visceral origin.
• Severe constipation or uncontrolled diabetes (HbA1c >10).
• Other medical conditions that would interfere with study participation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Louisville Clinical Trials Unit — Louisville

Publications

• 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. PMID 20420555
• 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. PMID 10201478
• 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. PMID 20003077
• 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 Interchang PMID 33548234
• 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. PMID 23414452
• 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. PMID 30734412

Identifiers

NCT: NCT07556237 · 26.0165 · 1UG3NS140971-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗