Diabetes, Gastroparesis
Conditions
Brief summary
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.
Detailed description
Each participant will be randomized to receive Percutaneous Electrical Nerve Field Stimulation (PENFS) treatment with or without stimulation. The study involves 6 study visits. Study procedures include: removing and replacing the PENFS device, questionnaires, ECG, assessment use of galvanic skin response (GSR), pneumatic belt to assess breathing, physical examine, and blood draws.
Interventions
DEVICEPERCUTANEOUS 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.
SHAM (no electrical charge)
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The Sham arm will have single blind masking. The participant will not know if they are in the Stimulation arm or the Sham arm; only the coordinator/tech will know the status of the arm.
Intervention model description
This is a double blind, randomized, sham controlled study. A total of 30 subjects will be enrolled at Indiana University and another 30 at Ohio State University) with 15 subjects in each arm (PENFS device or Sham (no electrical charge)).
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Wiling to have one teaspoon (5 ml) of blood drawn. * Diagnosed with gastroparesis for twelve months or longer * Diagnosed with diabetes either Type 1 or Type 2 * Documented delayed gastric emptying (\>10% retention of the test meal at four hours) on a standardized scrambled-egg scintigraphy gastric emptying test performed in the last two years. * Upper GI endoscopy indicating no mechanical obstruction performed in the last five years. * Symptoms of nausea and vomiting consistent with clinical diagnosis of gastroparesis (as opposed to other causes of nausea and vomiting such as mechanical obstruction, acute viral illness, chemotherapy, psychogenic vomiting. * Documented Hb A1c within three months of screening or at the time of screening (\<=8.0)
Exclusion criteria
* Unable to provide consent * Pregnant females * Medical records indicate intestinal pseudo-obstruction * Diagnosed with cardiac arrhythmia * History of prior gastric surgery * History of vagotomy * History of organ transplantation * History of seizures * Diagnosed with primary swallowing disorders * Subjects who are dependent on drugs like Marinol for their condition * Those diagnosed with psychogenic vomiting and not related to gastroparesis * Medically unstable subjects * Those at high surgical risk * Subjects taking narcotic analgesics daily. * Those with poorly controlled diabetes mellitus (Hgb A1c\>8) within three months of screening or at the time of screening. * Subjects diagnosed with hemophilia, psoriasis vulgaris are excluded * Those having a cardiac pacemaker will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastroparesis Cardinal Symptom Index Daily Dairy | Five weeks | ANMS GASTROPARESIS CARDINAL SYMPTOM INDEX - DAILY DIARY this tool uses a list of 7 criteria for rating gastric symptoms. The scale ratings are: None, Mild, Moderate, Severe, and Very Severe. |
| Change in Patient Assessment of Upper Gastrointestinal Disorder Symptoms | Five weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate Variability | Five weeks. | Heart Rate Variability is reported on a 0-100 scale. |
| Change in Anxiety | Five weeks | The General Anxiety Disorder (GAD)-7 scale is from 0-21, where 0= no anxiety and 21=severe anxiety |
| Change in the measure of depression | Five weeks | 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. |
Countries
United States
Contacts
CONTACTMaureen Schilling, BS
CONTACTLainna Cohen, MSW
PRINCIPAL_INVESTIGATORThomas V Nowak, MD
IU School of Medicine/IU Health
Outcome results
None listed