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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06783504
Status
Not Yet Recruiting

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Conditions

  • Diabetes
  • Gastroparesis

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • PERCUTANEOUS ELECTRICAL FIELD NERVE STIMULATION — DEVICE
    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.
  • Sham percutaneous electrical nerve field stimulation — DEVICE
    SHAM (no electrical charge)

Study Details

The purpose of this study is to find out if we can stimulate the vagus nerve. The vagus nerve is a largely internal nerve that controls many bodily functions, including stomach function. We hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then we hope that this will help our treatment of patients with nausea and vomiting and disordered stomach function.

Key Dates

Start date
Feb 10, 2027
Status verified
Apr 2026
Primary completion
Feb 28, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ACTIVE (electrical charge)
    The PENFS device is placed behind the patient's left ear and connected to stimulation needles on the auricle. The appliance transmits low-frequency electrical impulses throughout the auricle.
  • Sham Comparator: Sham percutaneous electrical nerve field stimulation (no electrical charge)
    The PENFS device is placed behind the patient's left ear and connected to stimulation needles on the auricle. The appliance will not transmit any electrical impulses.

Primary Outcome Measure

Change in Gastroparesis Cardinal Symptom Index Daily Dairy [ Time Frame: Five weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University HospitalIndianapolisIndiana46202
Maureen Schilling, BS
[email protected]
317-278-2064
Lainna Cohen, MSW
[email protected]
3172780621
Thomas V Nowak, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Indiana University Hospital· Indianapolis, IN

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