GastroparesisHEALNCT07556237
Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis
A study testing Enterra™ neurostimulator in people with Gastroparesis and Chronic Abdominal Pain, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis, Chronic Abdominal Pain
- What is being tested?
- Enterra™ neurostimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Louisville Clinical Trials Unit
Louisville, Kentucky, 40202
Thomas L Abell, MD, 502-588-4600, thomas.abell@louisville.edu
About this study
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.
Read the 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.
- Conditions
- Gastroparesis, Chronic Abdominal Pain
- Being tested
- Enterra™ neurostimulator
- Keywords
- Gastric Electrical Stimulation, Enterra, Visceral pain, Gastroparesis pain, Neuromodulation
- Medical subject headings
- Gastroparesis, Visceral Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enterra™ neurostimulatorDevice
Gastric Electrical Stimulation using implanted Enterra™ neurostimulator with protocol-specified programming parameters.
| Study group | Role | What they receive |
|---|---|---|
| Nominal GES Parameters | Active comparator | Continuous 24-hour gastric electrical stimulation using participants' standard clinically prescribed Enterra™ settings. Receives: 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. Receives: 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). Receives: Device: Enterra™ neurostimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 8 weeks after randomization.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Thomas Abell, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556237
- Sponsor's protocol ID
- 26.0165
- Other IDs
- 1UG3NS140971-01
- Acronym
- HEAL
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: De-identified individual participant data will not be shared outside the investigative team.
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.
PubMed 20420555Hoogerwerf 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.
PubMed 10201478Parkman 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.
PubMed 20003077Pasricha 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.
PubMed 33548234Hasler 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.
PubMed 23414452Revicki 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.
PubMed 30734412
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis
- ClinicalTrials.gov ID
- NCT07556237
- Acronym / sponsor ID
- HEAL / 26.0165
- Conditions
- Gastroparesis, Chronic Abdominal Pain
- Keywords
- Gastric Electrical Stimulation, Enterra, Visceral pain, Gastroparesis pain, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nominal GES Parameters | Active comparator | Device: Enterra™ neurostimulatorContinuous 24-hour gastric electrical stimulation using participants' standard clinically prescribed Enterra™ settings. |
| Special Parameter GES | Experimental | Device: Enterra™ neurostimulatorShort-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. |
| Modified Enterra Parameters | Experimental | Device: Enterra™ neurostimulatorContinuous 24-hour stimulation (3 seconds on / 2 seconds off; 0.33 ms pulse width; 14 Hz frequency; 15-20 mA amplitude). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enterra™ neurostimulatorGastric Electrical Stimulation using implanted Enterra™ neurostimulator with protocol-specified programming parameters. | Device | Modified Enterra Parameters, Nominal GES Parameters, Special Parameter GES |
Primary outcome
Change in Abdominal Pain Score
Time frame: Baseline to 8 weeks after randomization.
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).
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 20420555Gonzalez 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.
- Background: PubMed 10201478Hoogerwerf 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.
- Background: PubMed 20003077Parkman 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.
- Background: PubMed 33548234Pasricha 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.
- Background: PubMed 23414452Hasler 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.
- Background: PubMed 30734412Revicki 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.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be shared outside the investigative team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enterra™ neurostimulator in people with Gastroparesis and Chronic Abdominal Pain, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas L Abell, MD (502-588-4600, thomas.abell@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Abdominal Pain Score (time frame: Baseline to 8 weeks after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07556237, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.