Clinical Trial

Neuromodulation With Percutaneous Electrical Nerve Field Stimulation

Active, Not Recruiting
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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.
Trial Details
NCT Number NCT07492108
Lead Sponsor The Cleveland Clinic
Conditions Gastroparesis Like Symptoms
Enrollment 140 participants
Start Date 2026-01-08
Primary Completion 2027-06 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-03-25