An interventional study of PERCUTANEOUS ELECTRICAL FIELD NERVE STIMULATION and Sham percutaneous electrical nerve field stimulation in Diabetes and Gastroparesis, sponsored by Indiana University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Indiana University · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate whether stimulation of the vagus nerve can improve nausea and vomiting in diabetic gastroparetic patients.
The vagus nerve is one of the main determinants of gastrointestinal motility and gastric emptying. It has been speculated that neuropathy of the vagus nerve is the cause of the delay in gastric emptying in gastroparesis, the symptoms of which include nausea, vomiting, weight loss, early satiety, abdominal pain and bloating.
Percutaneous Electrical Nerve Field Stimulation (PENFS) has been approved by the FDA to treat adolescents with functional abdominal pain associated with irritable bowel syndrome. In this study, the impact of PENFS on gastroparesis symptoms will be evaluated.
After informed consent is obtained, participant eligibility will be assessed at a Screening Visit. A Hemoglobin A1C level (HgbA1c) will be drawn for this purpose. Eligible participants will then return for 5 Study Visits at which, they will:
Each participant will have a PENFS device applied at the study visits, however, participants are randomized to whether they will receive active stimulation during the study. The device will remain in place for 5 days after each visit. On the morning of Day 6 after each study visit, the participants will remove the PENFS device and return it at the next study visit.
Participants will also complete a daily diary to document symptoms over the previous 24 hours. Prior to each study visit, participants will be asked to refrain from caffeine on the day of the visit and to refrain from nicotine use for 24 hours prior to the visit.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: PERCUTANEOUS ELECTRICAL FIELD NERVE STIMULATION
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.
Device: Sham percutaneous electrical nerve field 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.
Also known as: IB-STIM
SHAM (no electrical charge)
Change in Gastroparesis Cardinal Symptom Index Daily Dairy
A modified version of the GASTROPARESIS CARDINAL SYMPTOM INDEX - DAILY DIARY (GCSI-DD) will be used. The questionnaire evaluates 4 gastroparesis symptoms (nausea, early satiety, postprandial fullness, upper abdominal pain) and asks participants to rate the severity of symptoms over the past 24 hours on a scale from 0 (none) to 4 (very severe). Additionally, vomiting episodes are reported (0 for none, 1 for one episode, 2 for two episodes, 3 for three episodes, or 4 for four or more episodes). Lower total scores indicate fewer or less severe symptoms.
Time frame: Baseline, Week 5
Change in Patient Assessment of Upper Gastrointestinal Disorder Symptoms
Scores are calculated by averaging the scores for each item in the subscale, with scores ranging from 0 (none or absent) to 5 (very severe). Optimal outcome would be a score of zero, no episodes/symptoms.
Time frame: Baseline, Week 5
Change in Heart Rate Variability
Heart Rate Variability is reported on a 0-100 scale.
Time frame: Baseline, Week 5
Change in Anxiety
The General Anxiety Disorder (GAD)-7 scale is from 0-21, where 0= no anxiety and 21=severe anxiety
Time frame: Baseline, Week 5
Change in the measure of depression
Patient Health Questionnaire (PHQ)-8 is a questionnaire that measures self-reported depressive systems. PHQ-8 uses a range from 0-24, where 0=no depressive symptoms and 24=severe symptoms.
Time frame: Baseline, Week 5
Change in Patient Assessment of Upper Gastrointestinal Disorder Symptoms by Diabetes Type
Scores are calculated by averaging the scores for each item in the subscale, with scores ranging from 0 (none or absent) to 5 (very severe). Optimal outcome would be a score of zero, no episodes/symptoms.
Time frame: Baseline, Week 5
Change in Gastroparesis Cardinal Symptom Index Daily Diary by Diabetes Type
A modified version of the GASTROPARESIS CARDINAL SYMPTOM INDEX - DAILY DIARY (GCSI-DD) will be used. The questionnaire evaluates 4 gastroparesis symptoms (nausea, early satiety, postprandial fullness, upper abdominal pain) and asks participants to rate the severity of symptoms over the past 24 hours on a scale from 0 (none) to 4 (very severe). Additionally, vomiting episodes are reported (0 for none, 1 for one episode, 2 for two episodes, 3 for three episodes, or 4 for four or more episodes). Lower total scores indicate fewer or less severe symptoms.
Time frame: Baseline, Week 5
Plan to share: No — All data and devices will be stored containing only the study subject number and dates of device usage. Sharing this data will not involve any IPD.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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