NCT07492108

Neuromodulation With Percutaneous Electrical Nerve Field Stimulation

Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Adults With Gastroparesis Like Symptoms: A Randomized, Double-Blind, Sham-Controlled Pilot Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroparesis Like Symptoms

Interventions

Type	Name	Description
DEVICE	Activated 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
DEVICE	Inactivated 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.

Timeline

• Start date: 2026-01-08
• Primary completion: 2027-06-01
• Completion: 2027-08-01
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study