A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders

Gisela Grotewold Chelimsky

Status: Terminated

Conditions: Nausea; Irritable Bowel Syndrome; Functional Gastrointestinal Disorders; Dyspepsia; Vagus Nerve Autonomic Disorder

Treatments: Device: Transcutaneous Electrical Nerve Stimulation (TENS); Device: Sham Transcutaneous Electrical Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04247100

HM20026558

Details and patient eligibility

About

The purpose of this study is to see if using a micro-current through a device called a TENS (Transcutaneous Electrical Nerve Stimulator) unit helps to improve functional gastrointestinal disorder (FGID) symptoms in children by stimulation of the vagus nerve. The study will compare two methods of stimulation to determine if there is a difference in the two methods.

Enrollment: 10 patients

Sex: Female

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients 12-18 years old with chronic idiopathic nausea, function abdominal pain, dyspepsia and/or irritable bowel syndrome
• English Speaking

Exclusion criteria

• Patients who are unable to stand upright during the heart rate variability recording
• Patients with a known bleeding disorder
• Gastric or cardiac pacer or defibrillator
• Poor circulation in lower limbs
• Swollen or inflamed outer ear
• Epilepsy
• Abdominal or inguinal hernia
• Any unstable medical condition, such as renal disease, uncontrolled diabetes, etc.
• Requires new medication during the 8 weeks of the study that may affect gastrointestinal symptoms, vagal modulation or immune response
• Inability to answer questionnaires or report pain on a 0-10 visual analog scale.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups

Active Stimulation (8)

Experimental group

Description:

Participants will receive active auricular microstimulation via TENS unit for 8 weeks. Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Sham Stimulation (4), Active (4)

Sham Comparator group

Description:

Participants will receive sham therapy via inactive TENS unit for 4 weeks, followed by active auricular microstimulation via TENS for 4 weeks. Under guidance from the study team, participants will self-administer the TENS therapy for two 1-hour periods a day for 8 weeks (4 weeks of therapy with inactive TENS, 4 weeks with active TENS).

Treatment:

Device: Sham Transcutaneous Electrical Nerve Stimulation

Device: Transcutaneous Electrical Nerve Stimulation (TENS)