Clinical trial NCT04247100: A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders
Official title: A Pilot Study of a Randomized Sham-control Auricular TENS Unit Stimulation to Improve Symptoms Through Vagal Modulation in Pediatric Functional Gastrointestinal Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Vagus Nerve Autonomic Disorder
Irritable Bowel Syndrome
Nausea
Dyspepsia
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 10
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Heart Rate Variability at 4 Weeks
timeFrame: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.
measure: Change in Heart Rate Variability at 8 Weeks
timeFrame: Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported.
measure: Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 4 Weeks (Basal Consumption)
timeFrame: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.
measure: Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 8 Weeks (Basal Consumption)
timeFrame: Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported.
measure: Change in Blood Cytokines Measured by TNF α Levels at 4 Weeks
timeFrame: Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.
measure: Change in Blood Cytokines Measured by TNF α Levels at 8 Weeks
timeFrame: Assessed at baseline, week 4, and week 8. Change in baseline to week 8.
Secondary outcomes:
measure: Change From Baseline in Functional Disability Inventory (Child and Adolescent)
timeFrame: Assessed at baseline, week 4, and week 8. Score changes from baseline to week 4 and baseline to week 8 are reported.
measure: Change From Baseline in Symptom Intensity Questionnaire
timeFrame: Assessed at baseline, week 4, and week 8. Changes per symptom score in baseline to week 4 and baseline to week 8 are reported.
measure: Change From Baseline in Pain Catastrophizing Scale (Child)
timeFrame: Assessed at baseline, week 4, and week 8. Score change in baseline to week 8 is reported.
measure: Change From Baseline in Revised Child Anxiety and Depression Scale
timeFrame: Assessed at baseline, week 4, and week 8. Changes in generalized anxiety & depression t-scores (translated from raw subscale scores) in baseline to week 4 and baseline to week 8 are reported.
measure: Change From Baseline in Functional Disability Inventory (Parent)
timeFrame: Assessed at baseline, week 4, and week 8. Score changes from baseline to week 4 and baseline to week 8 are reported.
measure: Change From Baseline in Pain Catastrophizing Scale (Parent)
timeFrame: Assessed at baseline, week 4, and week 8. Score change from baseline to week 8 is reported.
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Gisela Chelimsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kovacic K, Hainsworth K, Sood M, Chelimsky G, Unteutsch R, Nugent M, Simpson P, Miranda A. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):727-737. doi: 10.1016/S2468-1253(17)30253-4. Epub 2017 Aug 18.
citation: Brock C, Brock B, Aziz Q, Moller HJ, Pfeiffer Jensen M, Drewes AM, Farmer AD. Transcutaneous cervical vagal nerve stimulation modulates cardiac vagal tone and tumor necrosis factor-alpha. Neurogastroenterol Motil. 2017 May;29(5). doi: 10.1111/nmo.12999. Epub 2016 Dec 12.
citation: Ji RR, Xu ZZ, Gao YJ. Emerging targets in neuroinflammation-driven chronic pain. Nat Rev Drug Discov. 2014 Jul;13(7):533-48. doi: 10.1038/nrd4334. Epub 2014 Jun 20.