Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis

NCT07556237 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 26.01651UG3NS140971-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroparesis; Chronic Abdominal Pain

Keywords

Gastric Electrical Stimulation; Enterra; Visceral pain; Gastroparesis pain; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (7)

• Change in Brief Pain Inventory Score

  Baseline to 8 weeks after randomization.

• Change in Gastroparesis Cardinal Symptom Index score

  From baseline to 8 weeks after randomization

• Change in Pain Medications

  During the 8-week randomized treatment period.

• Percent Reduction in Pain Score

  Baseline to 8 weeks.

• Change in Inflammatory Cytokines

  Baseline to 8 weeks.

Study Arms (3)

Nominal GES Parameters

ACTIVE COMPARATOR

Continuous 24-hour gastric electrical stimulation using participants' standard clinically prescribed Enterra™ settings.

Device: Enterra™ neurostimulator

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.

Device: Enterra™ neurostimulator

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).

Device: Enterra™ neurostimulator

Interventions

Enterra™ neurostimulator DEVICE

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

Modified Enterra Parameters; Nominal GES Parameters; Special Parameter GES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Louisville Clinical Trials Unit

Louisville, Kentucky, 40202, United States

Location

Related Publications (6)

• 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 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.

  PMID: 10201478 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.

  PMID: 20003077 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.

  PMID: 33548234 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.

  PMID: 23414452 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.

  PMID: 30734412 BACKGROUND

MeSH Terms

Conditions

Gastroparesis; Visceral Pain

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nociceptive Pain; Pain

Central Study Contacts

Thomas L Abell, MD

CONTACT

502-588-4600; thomas.abell@louisville.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Device programming assignments are coded and implemented by an independent unblinded technician. Participants and study personnel remain blinded during the randomized treatment phase.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Arthur M Schoen MD Chair in Gastroenterology

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)