Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis (HEAL)

University of Louisville (UOFL)

Status: Begins enrollment in 1 month

Conditions: Chronic Abdominal Pain; Gastroparesis

Treatments: Device: Enterra™ neurostimulator

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07556237

1UG3NS140971-01 (U.S. NIH Grant/Contract)

26.0165

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups

Nominal GES Parameters

Active Comparator group

Description:

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

Treatment:

Device: Enterra™ neurostimulator

Special Parameter GES

Experimental group

Description:

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.

Treatment:

Device: Enterra™ neurostimulator

Modified Enterra Parameters

Experimental group

Description:

Continuous 24-hour stimulation (3 seconds on / 2 seconds off; 0.33 ms pulse width; 14 Hz frequency; 15-20 mA amplitude).

Treatment:

Device: Enterra™ neurostimulator