Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Louisville
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Daily opioid use.
Pregnancy or breastfeeding.
Abdominal pain not attributed to gastric/visceral origin.
Severe constipation or uncontrolled diabetes (HbA1c >10).
Trial design
Design model
Parallel
Treatments tested in this trial
Enterra™ neurostimulator
DeviceGastric Electrical Stimulation using implanted Enterra™ neurostimulator with protocol-specified programming parameters.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Nominal GES ParametersActive comparator 1 intervention
Group B: Special Parameter GESExperimental treatment 1 intervention
Group C: Modified Enterra ParametersExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
Baseline to 8 weeks after randomization.Secondary outcomes
1
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.
Time frame
Baseline to 8 weeks after randomization.2
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.
Time frame
From baseline to 8 weeks after randomization3
Change in Pain Medications
Change in use of opioid and non-opioid pain medications during the 8-week randomized treatment period.
Time frame
During the 8-week randomized treatment period.4
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.
Time frame
Baseline to 8 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Louisville
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov
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