Transcutaneous Electric Nerve Stimulation (TENS) for Vagal Modulation
NCT ID: NCT05987813
Last Updated: 2024-12-27
Study Results
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View full resultsBasic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2023-10-18
2024-06-04
Brief Summary
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Detailed Description
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Although functional gastrointestinal disorders (FGID) affect 10%-20% of children and adolescents. 1-3 the pathophysiology remains unknown. The multiple current hypotheses include visceral hypersensitivity, altered brain-gut connections, dysbiosis, genetic and epigenetic factors, and increased gut permeability among others. 4 Since the vagus nerve links the brain to the gut, many studies of adult subjects have evaluated the cardiovagal modulation in this group of disorders. The cardiovagal modulation can be measured by heart rate variability (HRV). HRV evaluates the heart rate fluctuation over a period of time. HRV is considered a reliable tool to look at parasympathetic function, baroreflex function, and parasympathetic to sympathetic balance.5, 6 High-frequency (hf) HRV is a marker of vagal modulation. The low-frequency (lf) HRV probably reflects cardiac autonomic outflow from the baroreflex or parasympathetic regulation, rather than sympathetic modulation, although this is still being discussed.6, 7
A meta-analysis of adult subjects with irritable bowel syndrome (IBS) showed decreased cardiovagal modulation.8 One study compared children aged 7-10 years of age with functional abdominal pain or IBS to healthy subjects. They found no difference in cardiovagal and cardiac sympathetic modulation.9 However, a study of young adolescents with different chronic pain syndromes, including chronic abdominal pain, showed decreased cardiovagal modulation.10 These findings are similar to those in many adult syndromes with chronic pain, such as chronic pelvic pain,11 complex regional pain syndrome,12 fibromyalgia,13 and chronic neck pain.14
Although future research would aim to investigate vagal modulation in those specifically with FGID, for preliminary data purposes we are testing the unit's effects on heart rate variability regardless of having/not having an FGID diagnosis.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FGID
Patients with a FGID
TENS Unit
Usage of the Transcutaneous Electrical Nerve Stimulation device for 2 hours a day.
Non-FGID
Patients without a FGID
TENS Unit
Usage of the Transcutaneous Electrical Nerve Stimulation device for 2 hours a day.
Interventions
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TENS Unit
Usage of the Transcutaneous Electrical Nerve Stimulation device for 2 hours a day.
Eligibility Criteria
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Inclusion Criteria
* 12 - 21 years old
* Either diagnosed OR not diagnosed with chronic idiopathic nausea, functional abdominal pain, dyspepsia and/or irritable bowel syndrome.
* English speaking
Exclusion Criteria
* 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)
12 Years
21 Years
FEMALE
Yes
Sponsors
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Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Gisela Chelimsky, MD
Role: PRINCIPAL_INVESTIGATOR
VCU
Locations
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Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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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.
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.
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.
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.
Riganello F, Garbarino S, Sannita WG. Heart Rate Variability, Homeostasis, and Brain Function. J Psychophysiol. 2012; 26: 178- 203.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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HM20025635
Identifier Type: -
Identifier Source: org_study_id