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

NCT04247100 | Terminated Results FDA Device

• 1 other identifier: HM20026558
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• Change in Heart Rate Variability at 4 Weeks

  EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control.

  Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.

• Change in Heart Rate Variability at 8 Weeks

  EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control.

  Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported.

• Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 4 Weeks (Basal Consumption)

  Blood draw will be tested for mitochondrial function by Seahorse assay, which measures Basal Oxygen Consumption Rate of live cells to provide insight into mitochondrial activity.

  Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.

• Change in Mitochondrial Bioenergetics Measured by Basal Oxygen Consumption Rate at 8 Weeks (Basal Consumption)

  Blood draw will be tested for mitochondrial function by Seahorse assay, which measures Basal Oxygen Consumption Rate of live cells to provide insight into mitochondrial activity.

  Assessed at baseline, week 4, and week 8. Change in baseline to week 8 is reported.

• Change in Blood Cytokines Measured by TNF α Levels at 4 Weeks

  Blood will be analyzed to detect changes in protein cytokine TNF α levels, an indicator for inflammation.

  Assessed at baseline, week 4, and week 8. Change in baseline to week 4 is reported.

• Change in Blood Cytokines Measured by TNF α Levels at 8 Weeks

  Blood will be analyzed to detect changes in protein cytokine TNF α levels, an indicator for inflammation

  Assessed at baseline, week 4, and week 8. Change in baseline to week 8.

Secondary Outcomes (6)

• Change From Baseline in Functional Disability Inventory (Child and Adolescent)

  Assessed at baseline, week 4, and week 8. Score changes from baseline to week 4 and baseline to week 8 are reported.

• Change From Baseline in Symptom Intensity Questionnaire

  Assessed at baseline, week 4, and week 8. Changes per symptom score in baseline to week 4 and baseline to week 8 are reported.

• Change From Baseline in Pain Catastrophizing Scale (Child)

  Assessed at baseline, week 4, and week 8. Score change in baseline to week 8 is reported.

• Change From Baseline in Revised Child Anxiety and Depression Scale

  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.

• Change From Baseline in Functional Disability Inventory (Parent)

  Assessed at baseline, week 4, and week 8. Score changes from baseline to week 4 and baseline to week 8 are reported.

Study Arms (2)

Active Stimulation (8)

EXPERIMENTAL

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.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Sham Stimulation (4), Active (4)

SHAM COMPARATOR

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).

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

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

Active Transcutaneous Auricular Microstimulation delivered by TENS device

Also known as: InTENSity Select Combo by Roscoe Medical

Active Stimulation (8); Sham Stimulation (4), Active (4)

Sham Transcutaneous Electrical Nerve Stimulation DEVICE

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

Also known as: InTENSity Select Combo by Roscoe Medical (Inactive)

Sham Stimulation (4), Active (4)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gisela Grotewold Chelimsky: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Related Publications (3)

• 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.

  PMID: 28826627 BACKGROUND

• 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.

  PMID: 27957782 BACKGROUND

• 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.

  PMID: 24948120 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases; Irritable Bowel Syndrome; Nausea; Dyspepsia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Gisela Chelimsky, MD
• Organization: Virginia Commonwealth University

gisela.chelimsky@vcuhealth.org

804-628-4859

Study Officials

• Gisela Chelimsky, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 29, 2020
• Study Start: September 1, 2020
• Primary Completion: August 23, 2021
• Study Completion: August 23, 2021
• Last Updated: October 12, 2023
• Results First Posted: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)