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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-08-23

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

30 participants will be enrolled in this double-blind sham control study. Fifteen participants will undergo sham stimulation for 4 weeks followed by active microstimulation for 4 weeks. The other 15 participants will have active microstimulation for all 8 weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Participants will be sent home at baseline with a TENS unit and a sealed envelope with instructions for device settings. The envelope will contain instructions for either sham stimulation or active stimulation (unknown to the performing coordinator and participant). Both groups will receive a new device and another set of instructions from the study team at 4 weeks. It is possible and permitted that the performing study coordinator will become aware of which group the subject is in when checking in on the subject.

Study Groups

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Active Stimulation (8)

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.

Group Type EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type DEVICE

Active Transcutaneous Auricular Microstimulation delivered by TENS device

Sham Stimulation (4), Active (4)

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).

Group Type SHAM_COMPARATOR

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type DEVICE

Active Transcutaneous Auricular Microstimulation delivered by TENS device

Sham Transcutaneous Electrical Nerve Stimulation

Intervention Type DEVICE

Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered

Interventions

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Transcutaneous Electrical Nerve Stimulation (TENS)

Active Transcutaneous Auricular Microstimulation delivered by TENS device

Intervention Type DEVICE

Sham Transcutaneous Electrical Nerve Stimulation

Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered

Intervention Type DEVICE

Other Intervention Names

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InTENSity Select Combo by Roscoe Medical InTENSity Select Combo by Roscoe Medical (Inactive)

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No