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

Indiana University

Status: Begins enrollment this month

Conditions: Diabetes; Gastroparesis

Treatments: Device: PERCUTANEOUS ELECTRICAL FIELD NERVE STIMULATION; Device: Sham percutaneous electrical nerve field stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06783504

18260

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

ACTIVE (electrical charge)

Active Comparator group

Description:

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.

Treatment:

Device: PERCUTANEOUS ELECTRICAL FIELD NERVE STIMULATION

Sham percutaneous electrical nerve field stimulation (no electrical charge)

Sham Comparator group

Description:

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.

Treatment:

Device: Sham percutaneous electrical nerve field stimulation