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Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma

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ClinicalTrials.gov Identifier: NCT03294616
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
Transtimulation Research, Inc
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
An innovative method of needleless transcutaneous electroacupuncture (TEA) using a newly developed watch-size stimulator is proposed. Weak electrical current will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. The stimulator can be attached to the skin near the acupuncture points and therefore daily activity of the patient does not need to be altered. Two experiments are designed to prove the feasibility of the proposed therapy for gastric complications of Scleroderma .

Condition or disease Intervention/treatment Phase
Scleroderma Gastroparesis Device: transcutaneous electroacupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma
Actual Study Start Date : February 6, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Experimental: scleroderma patients-0
for acute study: The experiment in patients will be performed in 4 randomized sessions on separate days (at least 3 days apart): one control session with sham-TEA and 3 TEA sessions at various parameters. TEA will be applied on both acupoints ST36 and PC6; the following sets of parameters will be tested for TEA at ST36: A) standard parameters: the set used in the previous SSc study: 25 Hz, 0.3ms, 2s-on and 3s-off; B) same as A but pulse width of 0.6ms; C) same as B but 0.1s-on and 0.4s-off. For TEA at PC6, 25 Hz will be replaced by 100Hz because TEA at PC6 is used to treat symptoms and 100Hz is believed to be better than 25Hz. The patient will be fasted overnight, and the test will last 2 hours (1 hour fasting and 1 hour postprandial).
Device: transcutaneous electroacupuncture
Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions
Other Name: TEA

Experimental: scleroderma patient-1
for chronic study: 2 weeks of Sham transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.
Device: transcutaneous electroacupuncture
Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions
Other Name: TEA

Experimental: scleroderma patients-2
for chronic study: 2 weeks of transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.
Device: transcutaneous electroacupuncture
Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions
Other Name: TEA




Primary Outcome Measures :
  1. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients [ Time Frame: 1 day ]
    On the first visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation

  2. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients [ Time Frame: 28 days ]
    On the second visit; The validated "University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0" (UCLA SCTC GIT2.0) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation

  3. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients [ Time Frame: 42 days ]
    On the third visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation

  4. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients [ Time Frame: 70 days ]
    The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation

  5. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients [ Time Frame: 1 day ]
    Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms

  6. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients [ Time Frame: 28 days ]
    Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms

  7. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients [ Time Frame: 42 days ]
    Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms

  8. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients [ Time Frame: 70 days ]
    Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms

  9. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients [ Time Frame: 1 day ]
    SF-36 questionnaire will be used to assess general quality of life

  10. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients [ Time Frame: 28 days ]
    SF-36 questionnaire will be used to assess general quality of life

  11. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients [ Time Frame: 42 days ]
    SF-36 questionnaire will be used to assess general quality of life

  12. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients [ Time Frame: 70 days ]
    SF-36 questionnaire will be used to assess general quality of life

  13. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients [ Time Frame: 1 day ]
    a validated method including 9 symptoms will be used to assess GI symptoms

  14. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients [ Time Frame: 28 days ]
    a validated method including 9 symptoms will be used to assess GI symptoms

  15. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients [ Time Frame: 42 days ]
    a validated method including 9 symptoms will be used to assess GI symptoms

  16. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients [ Time Frame: 70 days ]
    a validated method including 9 symptoms will be used to assess GI symptoms


Secondary Outcome Measures :
  1. effects of TEA on gastric motility [ Time Frame: 1 week ]
    visit 1 in acute phase; gastric slow waves recording

  2. effects of TEA on gastric motility [ Time Frame: 2 weeks ]
    visit 2 in acute phase; gastric slow waves recording

  3. effects of TEA on gastric motility [ Time Frame: 3 weeks ]
    visit 3 in acute phase; gastric slow waves recording

  4. effects of TEA on gastric motility [ Time Frame: 4 weeks ]
    visit 4 in acute phase; gastric slow waves recording

  5. effects of TEA on autonomic function [ Time Frame: 1 week ]
    visit 1 in acute phase; heart rate variability recording

  6. effects of TEA on autonomic function [ Time Frame: 2 weeks ]
    visit 2 in acute phase; heart rate variability recording

  7. effects of TEA on autonomic function [ Time Frame: 3 weeks ]
    visit 3 in acute phase; heart rate variability recording

  8. effects of TEA on autonomic function [ Time Frame: 4 weeks ]
    visit 4 in acute phase; heart rate variability recording

  9. effects of TEA on gastric motility [ Time Frame: 1 day ]
    visit 1 in chronic phase; gastric slow waves recording

  10. effects of TEA on gastric motility [ Time Frame: 28 days ]
    visit 2 in chronic phase; gastric slow waves recording

  11. effects of TEA on gastric motility [ Time Frame: 42 days ]
    visit 3 in chronic phase; gastric slow waves recording

  12. effects of TEA on gastric motility [ Time Frame: 70 days ]
    visit 4 in chronic phase; gastric slow waves recording

  13. effects of TEA on gastric motility [ Time Frame: 1 day ]
    visit 1 in chronic phase; breath test will be used to assess gastric emptying

  14. effects of TEA on gastric motility [ Time Frame: 28 days ]
    visit 2 in chronic phase; breath test will be used to assess gastric emptying

  15. effects of TEA on gastric motility [ Time Frame: 42 days ]
    visit 3 in chronic phase; breath test will be used to assess gastric emptying

  16. effects of TEA on gastric motility [ Time Frame: 70 days ]
    visit 4 in chronic phase; breath test will be used to assess gastric emptying

  17. effects of TEA on autonomic function [ Time Frame: 1 day ]
    visit 1 in chronic phase; heart rate variability recording

  18. effects of TEA on autonomic function [ Time Frame: 28 days ]
    visit 2 in chronic phase; heart rate variability recording

  19. effects of TEA on autonomic function [ Time Frame: 42 days ]
    visit 3 in chronic phase; heart rate variability recording

  20. effects of TEA on autonomic function [ Time Frame: 70 days ]
    visit 4 in chronic phase; heart rate variability recording

  21. effects of TEA on autonomic function [ Time Frame: 1 day ]
    visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function

  22. effects of TEA on autonomic function [ Time Frame: 28 days ]
    visit 2 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function

  23. effects of TEA on autonomic function [ Time Frame: 42 days ]
    visit 3 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function

  24. effects of TEA on autonomic function [ Time Frame: 70 days ]
    visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey visit 4 in chronic phase; will be used to assess autonomic function

  25. effects of TEA on autonomic function [ Time Frame: 1 day ]
    baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  26. effects of TEA on autonomic function [ Time Frame: 28 days ]
    baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  27. effects of TEA on autonomic function [ Time Frame: 42 days ]
    baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  28. effects of TEA on autonomic function [ Time Frame: 70 days ]
    baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  29. effects of TEA on autonomic function [ Time Frame: 1 day ]
    30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  30. effects of TEA on autonomic function [ Time Frame: 28 days ]
    30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  31. effects of TEA on autonomic function [ Time Frame: 42 days ]
    30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  32. effects of TEA on autonomic function [ Time Frame: 70 days ]
    30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  33. effects of TEA on autonomic function [ Time Frame: 1 day ]
    60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  34. effects of TEA on autonomic function [ Time Frame: 28 days ]
    60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  35. effects of TEA on autonomic function [ Time Frame: 42 days ]
    60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  36. effects of TEA on autonomic function [ Time Frame: 70 days ]
    60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

  37. effects of TEA on autonomic function [ Time Frame: 1 day ]
    baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  38. effects of TEA on autonomic function [ Time Frame: 28 days ]
    baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  39. effects of TEA on autonomic function [ Time Frame: 42 days ]
    baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  40. effects of TEA on autonomic function [ Time Frame: 70 days ]
    baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  41. effects of TEA on autonomic function [ Time Frame: 1 day ]
    30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  42. effects of TEA on autonomic function [ Time Frame: 28 days ]
    30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  43. effects of TEA on autonomic function [ Time Frame: 42 days ]
    30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  44. effects of TEA on autonomic function [ Time Frame: 70 days ]
    30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  45. effects of TEA on autonomic function [ Time Frame: 1 day ]
    60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  46. effects of TEA on autonomic function [ Time Frame: 28 days ]
    60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  47. effects of TEA on autonomic function [ Time Frame: 42 days ]
    60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  48. effects of TEA on autonomic function [ Time Frame: 70 days ]
    60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

  49. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 1 day ]
    baseline before the study; vasoactive intestinal peptide (VIP)

  50. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    baseline before the study; vasoactive intestinal peptide (VIP)

  51. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    baseline before the study; vasoactive intestinal peptide (VIP)

  52. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    baseline before the study; vasoactive intestinal peptide (VIP)

  53. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 1 day ]
    30 minutes after the testing meal; vasoactive intestinal peptide (VIP)

  54. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    30 minutes after the testing meal; vasoactive intestinal peptide (VIP)

  55. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    30 minutes after the testing meal; vasoactive intestinal peptide (VIP)

  56. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    30 minutes after the testing meal; vasoactive intestinal peptide (VIP)

  57. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 1 day ]
    60 minutes after the testing meal; vasoactive intestinal peptide (VIP)

  58. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    60 minutes after the testing meal; vasoactive intestinal peptide (VIP)

  59. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    60 minutes after the testing meal; vasoactive intestinal peptide (VIP)

  60. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    60 minutes after the testing meal; vasoactive intestinal peptide (VIP)

  61. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: day 1 ]
    baseline before the study; interleukin-10 (IL-10)

  62. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    baseline before the study; interleukin-10 (IL-10)

  63. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    baseline before the study; interleukin-10 (IL-10)

  64. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    baseline before the study; interleukin-10 (IL-10)

  65. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 1 day ]
    30 minutes after the testing meal; interleukin-10 (IL-10)

  66. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    30 minutes after the testing meal; interleukin-10 (IL-10)

  67. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    30 minutes after the testing meal; interleukin-10 (IL-10)

  68. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    30 minutes after the testing meal; interleukin-10 (IL-10)

  69. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 1 day ]
    60 minutes after the testing meal; interleukin-10 (IL-10)

  70. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    60 minutes after the testing meal; interleukin-10 (IL-10)

  71. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    60 minutes after the testing meal; interleukin-10 (IL-10)

  72. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    60 minutes after the testing meal; interleukin-10 (IL-10)

  73. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 1 day ]
    baseline before the study; interferon α(IFNα)

  74. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    baseline before the study; interferon α(IFNα)

  75. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    baseline before the study; interferon α(IFNα)

  76. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    baseline before the study; interferon α(IFNα)

  77. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 1 day ]
    30 minutes after the testing meal; interferon α(IFNα)

  78. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    30 minutes after the testing meal; interferon α(IFNα)

  79. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    30 minutes after the testing meal; interferon α(IFNα)

  80. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    30 minutes after the testing meal; interferon α(IFNα)

  81. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 1 day ]
    60 minutes after the testing meal; interferon α(IFNα)

  82. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    60 minutes after the testing meal; interferon α(IFNα)

  83. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    60 minutes after the testing meal; interferon α(IFNα)

  84. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    60 minutes after the testing meal; interferon α(IFNα)

  85. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 1 day ]
    baseline before the study; interleukin-1 beta (IL-1β)

  86. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    baseline before the study; interleukin-1 beta (IL-1β)

  87. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    baseline before the study; interleukin-1 beta (IL-1β)

  88. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    baseline before the study; interleukin-1 beta (IL-1β)

  89. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 1 day ]
    30 minutes after the testing meal; interleukin-1 beta (IL-1β)

  90. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    30 minutes after the testing meal; interleukin-1 beta (IL-1β)

  91. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    30 minutes after the testing meal; interleukin-1 beta (IL-1β)

  92. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    30 minutes after the testing meal; interleukin-1 beta (IL-1β)

  93. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 1 day ]
    60 minutes after the testing meal; interleukin-1 beta (IL-1β)

  94. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    60 minutes after the testing meal; interleukin-1 beta (IL-1β)

  95. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    60 minutes after the testing meal; interleukin-1 beta (IL-1β)

  96. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    60 minutes after the testing meal; interleukin-1 beta (IL-1β)

  97. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 1 day ]
    baseline before the study; interleukin-6 (IL-6)

  98. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    baseline before the study; interleukin-6 (IL-6)

  99. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    baseline before the study; interleukin-6 (IL-6)

  100. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    baseline before the study; interleukin-6 (IL-6)

  101. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 1 day ]
    30 minutes after the testing meal; interleukin-6 (IL-6)

  102. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    30 minutes after the testing meal; interleukin-6 (IL-6)

  103. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    30 minutes after the testing meal; interleukin-6 (IL-6)

  104. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    30 minutes after the testing meal; interleukin-6 (IL-6)

  105. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 1 day ]
    60 minutes after the testing meal; interleukin-6 (IL-6)

  106. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    60 minutes after the testing meal; interleukin-6 (IL-6)

  107. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    60 minutes after the testing meal; interleukin-6 (IL-6)

  108. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    60 minutes after the testing meal; interleukin-6 (IL-6)

  109. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: day 1 ]
    baseline before the study; tumor necrosis factor alpha(TNFα)

  110. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    baseline before the study; tumor necrosis factor alpha(TNFα)

  111. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    baseline before the study; tumor necrosis factor alpha(TNFα)

  112. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    baseline before the study; tumor necrosis factor alpha(TNFα)

  113. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 1 day ]
    30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

  114. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

  115. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

  116. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

  117. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 1 day ]
    60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

  118. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 28 days ]
    60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

  119. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 42 days ]
    60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

  120. effects of TEA on GI hormones and inflammatory cytokine [ Time Frame: 70 days ]
    60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No any systemic diseases;
  • no scleroderma; no history of gastrointestinal surgery;
  • no dyspeptic symptoms during the past 2 weeks;
  • not taking any medications except contraceptives during the past 2 weeks;
  • age 18 and older.

Exclusion Criteria:

  • History of any systemic diseases or surgeries;
  • allergic to adhesives; pregnancy;
  • unable to sign the consent form.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294616


Contacts
Contact: Jiande Chen, Ph.D 832-640-8111 jchen184@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Jiande Chen, PhD    832-640-8111    Jchen184@jhmi.edu   
Contact: Jieyun Yin, PhD    8322027068    jieyun.yin@jhmi.edu   
Sub-Investigator: Xue Jin, MD         
Sponsors and Collaborators
Johns Hopkins University
Transtimulation Research, Inc
Investigators
Principal Investigator: Jiande Chen, Ph.D Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03294616     History of Changes
Other Study ID Numbers: IRB00089514
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: haven't decided yet.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
transcutaneous electroacupuncture

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Gastroparesis
Connective Tissue Diseases
Skin Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms