Trials / Terminated
TerminatedNCT04247100
A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders
A Pilot Study of a Randomized Sham-control Auricular TENS Unit Stimulation to Improve Symptoms Through Vagal Modulation in Pediatric Functional Gastrointestinal Disorders
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Gisela Grotewold Chelimsky · Academic / Other
- Sex
- Female
- Age
- 12 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Functional Gastrointestinal Disorders
- Vagus Nerve Autonomic Disorder
- Irritable Bowel Syndrome
- Nausea
- Dyspepsia
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcutaneous Electrical Nerve Stimulation (TENS) | Active Transcutaneous Auricular Microstimulation delivered by TENS device |
| 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 |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2021-08-23
- Completion
- 2021-08-23
- First posted
- 2020-01-29
- Last updated
- 2023-10-12
- Results posted
- 2023-10-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04247100. Inclusion in this directory is not an endorsement.