Transcutaneous Electric Nerve Stimulation (TENS) for Vagal Modulation

NCT05987813 | Terminated Results DMC FDA Device

• 1 other identifier: HM20025635
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to determine if the auricular microstimulator produces the expected increase in HRV.

Conditions

Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (2)

• Change in High-frequency Heart Rate Variability (hfHRV) at 4 Weeks

  Determine if microstimulation over a 4 week period results in improvement in hfHRV power. Average hfHRV power was calculated at baseline and 4 weeks. The change in average hfHRV power in milliseconds squared from baseline to 4 weeks was calculated for each participant. The average change for each group is reported.

  Assessed at baseline and 4 weeks.

• Rate of Compliance With Daily TENS Usage

  Determine the compliance rate of adolescents utilizing a microstimulator. Compliance rate calculated as number of minutes unit was used (summed from all self-report daily recording journals) divided by 3360 (the total number of minutes the unit could have been used if the participant used it for 2 hours daily for 4 weeks). The rate average for each group is reported.

  Assessed daily for duration of study (4 weeks) via self-report recording journal.

Study Arms (2)

FGID

EXPERIMENTAL

Patients with a FGID

Device: TENS Unit

Non-FGID

EXPERIMENTAL

Patients without a FGID

Device: TENS Unit

Interventions

TENS Unit DEVICE

Usage of the Transcutaneous Electrical Nerve Stimulation device for 2 hours a day.

FGID; Non-FGID

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female
• years old
• Either diagnosed OR not diagnosed with chronic idiopathic nausea, functional 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
• Patients with swollen, infected, inflamed, or other skin eruptions on outer ear
• Patients with epilepsy
• Patients with any implanted cardiac pacemaker or defibrillator
• Patients with serious arterial circulatory problems in the lower limbs
• Patients with abdominal or inguinal hernia
• Patients who are pregnant
• Any unstable medical condition, such as renal disease, uncontrolled diabetes, etc.
• Requires new medication during the 4 weeks of the study that may affect the gastrointestinal symptoms, vagal modulation or immune response.
• Practices over 1 hour of aerobic activity a day
• Daily practice of abdominal breathing (yoga)

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Related Publications (15)

• Hyams JS, Davis P, Sylvester FA, Zeiter DK, Justinich CJ, Lerer T. Dyspepsia in children and adolescents: a prospective study. J Pediatr Gastroenterol Nutr. 2000 Apr;30(4):413-8. doi: 10.1097/00005176-200004000-00012.

  PMID: 10776953 BACKGROUND

• APLEY J, NAISH N. Recurrent abdominal pains: a field survey of 1,000 school children. Arch Dis Child. 1958 Apr;33(168):165-70. doi: 10.1136/adc.33.168.165. No abstract available.

  PMID: 13534750 BACKGROUND

• Boey C, Yap S, Goh KL. The prevalence of recurrent abdominal pain in 11- to 16-year-old Malaysian schoolchildren. J Paediatr Child Health. 2000 Apr;36(2):114-6. doi: 10.1046/j.1440-1754.2000.00465.x.

  PMID: 10760006 BACKGROUND

• Enck P, Aziz Q, Barbara G, Farmer AD, Fukudo S, Mayer EA, Niesler B, Quigley EM, Rajilic-Stojanovic M, Schemann M, Schwille-Kiuntke J, Simren M, Zipfel S, Spiller RC. Irritable bowel syndrome. Nat Rev Dis Primers. 2016 Mar 24;2:16014. doi: 10.1038/nrdp.2016.14.

  PMID: 27159638 BACKGROUND

• Riganello F, Garbarino S, Sannita WG. Heart Rate Variability, Homeostasis, and Brain Function. J Psychophysiol. 2012; 26: 178- 203.

  BACKGROUND

• Goldstein DS, Bentho O, Park MY, Sharabi Y. Low-frequency power of heart rate variability is not a measure of cardiac sympathetic tone but may be a measure of modulation of cardiac autonomic outflows by baroreflexes. Exp Physiol. 2011 Dec;96(12):1255-61. doi: 10.1113/expphysiol.2010.056259. Epub 2011 Sep 2.

  PMID: 21890520 BACKGROUND

• Reyes del Paso GA, Langewitz W, Mulder LJ, van Roon A, Duschek S. The utility of low frequency heart rate variability as an index of sympathetic cardiac tone: a review with emphasis on a reanalysis of previous studies. Psychophysiology. 2013 May;50(5):477-87. doi: 10.1111/psyp.12027. Epub 2013 Feb 27.

  PMID: 23445494 BACKGROUND

• Liu Q, Wang EM, Yan XJ, Chen SL. Autonomic functioning in irritable bowel syndrome measured by heart rate variability: a meta-analysis. J Dig Dis. 2013 Dec;14(12):638-46. doi: 10.1111/1751-2980.12092.

  PMID: 23927739 BACKGROUND

• Jarrett M, Heitkemper M, Czyzewski D, Zeltzer L, Shulman RJ. Autonomic nervous system function in young children with functional abdominal pain or irritable bowel syndrome. J Pain. 2012 May;13(5):477-84. doi: 10.1016/j.jpain.2012.02.007. Epub 2012 Apr 20.

  PMID: 22520688 BACKGROUND

• Evans S, Seidman LC, Tsao JC, Lung KC, Zeltzer LK, Naliboff BD. Heart rate variability as a biomarker for autonomic nervous system response differences between children with chronic pain and healthy control children. J Pain Res. 2013 Jun 12;6:449-57. doi: 10.2147/JPR.S43849. Print 2013.

  PMID: 23788839 BACKGROUND

• Williams DP, Chelimsky G, McCabe NP, Koenig J, Singh P, Janata J, Thayer JF, Buffington CA, Chelimsky T. Effects of Chronic Pelvic Pain on Heart Rate Variability in Women. J Urol. 2015 Nov;194(5):1289-94. doi: 10.1016/j.juro.2015.04.101. Epub 2015 May 9.

  PMID: 25963185 BACKGROUND

• Mork PJ, Nilsson J, Loras HW, Riva R, Lundberg U, Westgaard RH. Heart rate variability in fibromyalgia patients and healthy controls during non-REM and REM sleep: a case-control study. Scand J Rheumatol. 2013;42(6):505-8. doi: 10.3109/03009742.2012.755564. Epub 2013 Feb 20.

  PMID: 23425526 BACKGROUND

• Terkelsen AJ, Molgaard H, Hansen J, Finnerup NB, Kroner K, Jensen TS. Heart rate variability in complex regional pain syndrome during rest and mental and orthostatic stress. Anesthesiology. 2012 Jan;116(1):133-46. doi: 10.1097/ALN.0b013e31823bbfb0.

  PMID: 22089824 BACKGROUND

• Kang JH, Chen HS, Chen SC, Jaw FS. Disability in patients with chronic neck pain: heart rate variability analysis and cluster analysis. Clin J Pain. 2012 Nov-Dec;28(9):797-803. doi: 10.1097/AJP.0b013e3182442afd.

  PMID: 22751023 BACKGROUND

• Chelimsky G, Rausch S, Bierer D, Feng M, Simpson P, Awe E, Chelimsky T. Cardiovagal modulation in pediatric functional gastrointestinal disorders. Neurogastroenterol Motil. 2019 May;31(5):e13564. doi: 10.1111/nmo.13564. Epub 2019 Mar 27.

  PMID: 30916860 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Results Point of Contact

• Title: Gisela Chelimsky
• Organization: Virginia Commonwealth University

gisela.chelimsky@vcuhealth.org

804-628-5882

Study Officials

• Gisela Chelimsky, MD

  VCU

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: FGID group, non-FGID group. Assigned to 2 hours of daily TENS usage

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: October 18, 2023
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: December 27, 2024
• Results First Posted: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)