Gastroparesis Like SymptomsNCT07492108
Neuromodulation With Percutaneous Electrical Nerve Field Stimulation
A study testing Activated IB-Stim Device and Inactivated IB-Stim Device in people with Gastroparesis Like Symptoms, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The IB-Stim is the first device to be approved by the Food and Drug Administration (FDA) for the treatment of functional abdominal pain in adolescents aged 11-18 with IBS. However, the efficacy of Percutaneous electrical nerve field stimulation (PENFS) in adults with gastroparesis like symptoms (GPLS) is not currently… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastroparesis Like Symptoms
- What is being tested?
- Activated IB-Stim Device and Inactivated IB-Stim Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2026to Aug 2027
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ability to provide written, informed consent
- Patients who meet Rome IV criteria for Functional Dyspepsia (FD), with or without a delay in gastric emptying:
- One or more of the following: Bothersome postprandial fullness, Bothersome early satiation, Bothersome epigastric pain, Bothersome epigastric burning
- No evidence of structural disease that is likely to explain the symptoms
- Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
- Average daily worst abdominal pain score between 4 and 8 (on a 0-10-point rating scale) during the screening period. A minimum reporting of abdominal pain will be required for 5/7 days in the baseline period.
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- Minimum of 2 days of abdominal pain/week prior to starting trial.
- At least moderate symptom severity with a GCSI score of at least 2.0 during screening
- If receiving pharmacologic therapy for abdominal pain associated with GPLS, doses must be stable for at least 60 days prior to randomization.
- If receiving pharmacologic therapy for GPLS that does not have an effect on abdominal pain, doses must be stable for at least 30 days prior to randomization.
Who cannot join
- Patients under the age of 18 years or over the age of 60 years
- Patients who cannot provide informed consent or do not speak English
- Co-morbid, organic medical conditions associated with abdominal pain, including: Inflammatory bowel disease, chronic liver disease, peptic ulcer disease, celiac disease, diverticulitis, appendicitis, colorectal cancer, endometriosis, pregnancy, other intestinal or extra-intestinal malignancies. Patients with overlapping functional GI disorders (i.e. IBS) will not be excluded as long as GPLS is their predominant disorder
- Patients prescribed GLP-1s
- History of surgery involving Cranial Nerves V, VII, IX, or X.
- History of abdominal surgeries other than appendectomy or cholecystectomy at least 6 months before the screening visit.
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- Patients with chronic opioid, benzodiazepine, or illicit substance use within the last 6 months.
- Patients with underlying neurologic conditions, including history of: seizures, CVA, uncontrolled migraines, traumatic brain injury, multiple sclerosis
- Patients with severe, uncontrolled psychiatric conditions, including severe major depression, psychosis, dissociative episodes, etc.
- Patients with dermatologic conditions affecting the ear, face, or neck region (i.e. psoriasis), or with cuts or abrasions to the external ear that would interfere with needle placement
- Patients with hemophilia or other bleeding disorders
- Patients with any implanted electrical device
- Patients who are known to be pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Adults With Gastroparesis Like Symptoms: A Randomized, Double-Blind, Sham-Controlled Pilot Study
The IB-Stim is the first device to be approved by the Food and Drug Administration (FDA) for the treatment of functional abdominal pain in adolescents aged 11-18 with IBS. However, the efficacy of Percutaneous electrical nerve field stimulation (PENFS) in adults with gastroparesis like symptoms (GPLS) is not currently known. This study is a double-blind, randomized, sham-controlled pilot study evaluating the efficacy of PENFS using IB-Stim in adult patients with GPLS. A secondary aim will be to assess whether treatment with PENFS is associated with changes in autonomic function via heart rate variability.
- Conditions
- Gastroparesis Like Symptoms
- Being tested
- Activated IB-Stim Device, Inactivated IB-Stim Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated IB-Stim DeviceDevice
The electrode/needle arrays are placed according to the individual's arterial and cranial nerve anatomy. The exact location of the placement may vary slightly from person to person but is determined by both knowledge of auricular neuro-anatomy and visualization of the neurovascular bundles by transillumination (NEURAXIS, Versailles, IN, USA). The points will be targeted by four-point electrical stimulation using the device after carefully disinfecting the ear. The small device will be positioned and secured behind the ear similar to a hearing aid, which may be covered by hair. Neurostimulation will be delivered below sensation threshold for 5 consecutive days. The device will be applied by a trained provider. A total of 4 weeks of neurostimulation will be performed
Inactivated IB-Stim DeviceDevice
This control device will be identical in every way to the active device except it will lack the battery. The devices will be "made to order" when requested by the PI and will be shipped packaged as above. Both the subjects and the doctors placing the devices will be blinded, as the treatment and inactive devices will look identical with identical packaging and placement procedures.
| Study group | Role | What they receive |
|---|---|---|
| Active PENFS Device | Active comparator | Participants in this arm have active PENFS device stimulation Receives: Device: Activated IB-Stim Device |
| Control Arm | Sham comparator | Participants in this arm have inactive PENFS device Receives: Device: Inactivated IB-Stim Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in abdominal pain scores (on a 0-10 point rating scale, where 10 is the worst) from Baseline to Week 4
The primary goal of the analysis plan will be to test the effectiveness of IB-Stim neurostimulation versus sham in decreasing abdominal pain scores.
Measured: From Baseline through Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start8 Jan 2026
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroparesis Like SymptomsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madison Simons, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492108
- Sponsor's protocol ID
- 25-827
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Adults With Gastroparesis Like Symptoms: A Randomized, Double-Blind, Sham-Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07492108
- Acronym / sponsor ID
- 25-827
- Conditions
- Gastroparesis Like Symptoms
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 25 Mar 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.
The IB-Stim is the first device to be approved by the Food and Drug Administration (FDA) for the treatment of functional abdominal pain in adolescents aged 11-18 with IBS. However, the efficacy of Percutaneous electrical nerve field stimulation (PENFS) in adults with gastroparesis like symptoms (GPLS) is not currently known. This study is a double-blind, randomized, sham-controlled pilot study evaluating the efficacy of PENFS using IB-Stim in adult patients with GPLS. A secondary aim will be to assess whether treatment with PENFS is associated with changes in autonomic function via heart rate variability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active PENFS Device | Active comparator | Device: Activated IB-Stim DeviceParticipants in this arm have active PENFS device stimulation |
| Control Arm | Sham comparator | Device: Inactivated IB-Stim DeviceParticipants in this arm have inactive PENFS device |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Ability to provide written, informed consent
- Patients who meet Rome IV criteria for Functional Dyspepsia (FD), with or without a delay in gastric emptying:
- Average daily worst abdominal pain score between 4 and 8 (on a 0-10-point rating scale) during the screening period. A minimum reporting of abdominal pain will be required for 5/7 days in the baseline period.
- Minimum of 2 days of abdominal pain/week prior to starting trial.
- At least moderate symptom severity with a GCSI score of at least 2.0 during screening
Key exclusion criteria (13 listed)
- Patients under the age of 18 years or over the age of 60 years
- Patients who cannot provide informed consent or do not speak English
- Co-morbid, organic medical conditions associated with abdominal pain, including: Inflammatory bowel disease, chronic liver disease, peptic ulcer disease, celiac disease, diverticulitis, appendicitis, colorectal cancer, endometriosis, pregnancy, other intestinal or extra-intestinal malignancies. Patients with overlapping functional GI disorders (i.e. IBS) will not be excluded as long as GPLS is their predominant disorder
- Patients prescribed GLP-1s
- History of surgery involving Cranial Nerves V, VII, IX, or X.
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 |
|---|---|---|
| Activated IB-Stim DeviceThe electrode/needle arrays are placed according to the individual's arterial and cranial nerve anatomy. The exact location of the placement may vary slightly from person to person but is determined by both knowledge of auricular neuro-anatomy and visualization of the neurovascular bundles by transillumination (NEURAXIS, Versailles, IN, USA). The points will be targeted by four-point electrical stimulation using the device after carefully disinfecting the ear. The small device will be positioned and secured behind the ear similar to a hearing aid, which may be covered by hair. Neurostimulation will be delivered below sensation threshold for 5 consecutive days. The device will be applied by a trained provider. A total of 4 weeks of neurostimulation will be performed | Device | Active PENFS Device |
| Inactivated IB-Stim DeviceThis control device will be identical in every way to the active device except it will lack the battery. The devices will be "made to order" when requested by the PI and will be shipped packaged as above. Both the subjects and the doctors placing the devices will be blinded, as the treatment and inactive devices will look identical with identical packaging and placement procedures. | Device | Control Arm |
Primary outcome
Change in abdominal pain scores (on a 0-10 point rating scale, where 10 is the worst) from Baseline to Week 4
Time frame: From Baseline through Week 4
The primary goal of the analysis plan will be to test the effectiveness of IB-Stim neurostimulation versus sham in decreasing abdominal pain scores.
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 25 Mar 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activated IB-Stim Device and Inactivated IB-Stim Device in people with Gastroparesis Like Symptoms, run by The Cleveland Clinic 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 10 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 25 Mar 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in abdominal pain scores (on a 0-10 point rating scale, where 10 is the worst) from Baseline to Week 4 (time frame: From Baseline through Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2026.