Neuromodulation With Percutaneous Electrical Nerve Field Stimulation

NeuroTherapia, Inc.

Status

Active, not recruiting

Conditions

Gastroparesis Like Symptoms

Treatments

Device: Inactivated IB-Stim Device

Device: Activated IB-Stim Device

Study type

Interventional

Funder types

Other

Identifiers

NCT07492108

25-827

Details and patient eligibility

About

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.

Enrollment

140 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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