Effect Of Percutaneous Electrical Nerve Field Stimulation on Symptom Control/Nervous System Activity in Patients w/Diabetes Types 1/2

NANot yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 10, 2026

Primary Completion Date

February 28, 2027

Study Completion Date

August 31, 2027

Conditions
DiabetesGastroparesis
Interventions
DEVICE

PERCUTANEOUS ELECTRICAL FIELD NERVE STIMULATION

The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-Stim is intended to be used for 120 hours per week up to 3 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS.

DEVICE

Sham percutaneous electrical nerve field stimulation

SHAM (no electrical charge)

Trial Locations (1)

46202

Indiana University Hospital, Indianapolis

All Listed Sponsors
lead

Indiana University

OTHER