Gastroparesis Like Symptoms
Conditions
Brief 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 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.
Interventions
DEVICEActivated IB-Stim Device
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
DEVICEInactivated IB-Stim Device
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.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in abdominal pain scores (on a 0-10 point rating scale, where 10 is the worst) from Baseline to Week 4 | 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. |
Countries
United States
Outcome results
None listed