Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma

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 .

Study Overview

• Status: Completed
• Conditions: Gastroparesis; Scleroderma
• Intervention / Treatment: Device: transcutaneous electroacupuncture

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: TEA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	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	1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	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	28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	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	42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	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	70 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms	1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms	28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms	42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms	70 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	SF-36 questionnaire will be used to assess general quality of life	1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	SF-36 questionnaire will be used to assess general quality of life	28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	SF-36 questionnaire will be used to assess general quality of life	42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	SF-36 questionnaire will be used to assess general quality of life	70 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	a validated method including 9 symptoms will be used to assess GI symptoms	1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	a validated method including 9 symptoms will be used to assess GI symptoms	28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	a validated method including 9 symptoms will be used to assess GI symptoms	42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	a validated method including 9 symptoms will be used to assess GI symptoms	70 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effects of TEA on gastric motility	visit 1 in acute phase; gastric slow waves recording	1 week
effects of TEA on gastric motility	visit 2 in acute phase; gastric slow waves recording	2 weeks
effects of TEA on gastric motility	visit 3 in acute phase; gastric slow waves recording	3 weeks
effects of TEA on gastric motility	visit 4 in acute phase; gastric slow waves recording	4 weeks
effects of TEA on autonomic function	visit 1 in acute phase; heart rate variability recording	1 week
effects of TEA on autonomic function	visit 2 in acute phase; heart rate variability recording	2 weeks
effects of TEA on autonomic function	visit 3 in acute phase; heart rate variability recording	3 weeks
effects of TEA on autonomic function	visit 4 in acute phase; heart rate variability recording	4 weeks
effects of TEA on gastric motility	visit 1 in chronic phase; gastric slow waves recording	1 day
effects of TEA on gastric motility	visit 2 in chronic phase; gastric slow waves recording	28 days
effects of TEA on gastric motility	visit 3 in chronic phase; gastric slow waves recording	42 days
effects of TEA on gastric motility	visit 4 in chronic phase; gastric slow waves recording	70 days
effects of TEA on gastric motility	visit 1 in chronic phase; breath test will be used to assess gastric emptying	1 day
effects of TEA on gastric motility	visit 2 in chronic phase; breath test will be used to assess gastric emptying	28 days
effects of TEA on gastric motility	visit 3 in chronic phase; breath test will be used to assess gastric emptying	42 days
effects of TEA on gastric motility	visit 4 in chronic phase; breath test will be used to assess gastric emptying	70 days
effects of TEA on autonomic function	visit 1 in chronic phase; heart rate variability recording	1 day
effects of TEA on autonomic function	visit 2 in chronic phase; heart rate variability recording	28 days
effects of TEA on autonomic function	visit 3 in chronic phase; heart rate variability recording	42 days
effects of TEA on autonomic function	visit 4 in chronic phase; heart rate variability recording	70 days
effects of TEA on autonomic function	visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function	1 day
effects of TEA on autonomic function	visit 2 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function	28 days
effects of TEA on autonomic function	visit 3 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function	42 days
effects of TEA on autonomic function	visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey visit 4 in chronic phase; will be used to assess autonomic function	70 days
effects of TEA on autonomic function	baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.	1 day
effects of TEA on autonomic function	baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.	28 days
effects of TEA on autonomic function	baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.	42 days
effects of TEA on autonomic function	baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.	70 days
effects of TEA on autonomic function	30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.	1 day
effects of TEA on autonomic function	30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.	28 days
effects of TEA on autonomic function	30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.	42 days
effects of TEA on autonomic function	30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.	70 days
effects of TEA on autonomic function	60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.	1 day
effects of TEA on autonomic function	60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.	28 days
effects of TEA on autonomic function	60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.	42 days
effects of TEA on autonomic function	60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.	70 days
effects of TEA on autonomic function	baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.	1 day
effects of TEA on autonomic function	baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.	28 days
effects of TEA on autonomic function	baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.	42 days
effects of TEA on autonomic function	baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.	70 days
effects of TEA on autonomic function	30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.	1 day
effects of TEA on autonomic function	30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.	28 days
effects of TEA on autonomic function	30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.	42 days
effects of TEA on autonomic function	30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.	70 days
effects of TEA on autonomic function	60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.	1 day
effects of TEA on autonomic function	60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.	28 days
effects of TEA on autonomic function	60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.	42 days
effects of TEA on autonomic function	60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.	70 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; vasoactive intestinal peptide (VIP)	1 day
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; vasoactive intestinal peptide (VIP)	28 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; vasoactive intestinal peptide (VIP)	42 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; vasoactive intestinal peptide (VIP)	70 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; vasoactive intestinal peptide (VIP)	1 day
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; vasoactive intestinal peptide (VIP)	28 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; vasoactive intestinal peptide (VIP)	42 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; vasoactive intestinal peptide (VIP)	70 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; vasoactive intestinal peptide (VIP)	1 day
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; vasoactive intestinal peptide (VIP)	28 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; vasoactive intestinal peptide (VIP)	42 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; vasoactive intestinal peptide (VIP)	70 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-10 (IL-10)	day 1
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-10 (IL-10)	28 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-10 (IL-10)	42 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-10 (IL-10)	70 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-10 (IL-10)	1 day
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-10 (IL-10)	28 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-10 (IL-10)	42 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-10 (IL-10)	70 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-10 (IL-10)	1 day
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-10 (IL-10)	28 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-10 (IL-10)	42 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-10 (IL-10)	70 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interferon α(IFNα)	1 day
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interferon α(IFNα)	28 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interferon α(IFNα)	42 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interferon α(IFNα)	70 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interferon α(IFNα)	1 day
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interferon α(IFNα)	28 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interferon α(IFNα)	42 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interferon α(IFNα)	70 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interferon α(IFNα)	1 day
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interferon α(IFNα)	28 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interferon α(IFNα)	42 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interferon α(IFNα)	70 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-1 beta (IL-1β)	1 day
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-1 beta (IL-1β)	28 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-1 beta (IL-1β)	42 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-1 beta (IL-1β)	70 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-1 beta (IL-1β)	1 day
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-1 beta (IL-1β)	28 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-1 beta (IL-1β)	42 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-1 beta (IL-1β)	70 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-1 beta (IL-1β)	1 day
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-1 beta (IL-1β)	28 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-1 beta (IL-1β)	42 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-1 beta (IL-1β)	70 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-6 (IL-6)	1 day
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-6 (IL-6)	28 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-6 (IL-6)	42 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-6 (IL-6)	70 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-6 (IL-6)	1 day
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-6 (IL-6)	28 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-6 (IL-6)	42 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-6 (IL-6)	70 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-6 (IL-6)	1 day
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-6 (IL-6)	28 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-6 (IL-6)	42 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-6 (IL-6)	70 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; tumor necrosis factor alpha(TNFα)	day 1
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; tumor necrosis factor alpha(TNFα)	28 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; tumor necrosis factor alpha(TNFα)	42 days
effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; tumor necrosis factor alpha(TNFα)	70 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)	1 day
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)	28 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)	42 days
effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)	70 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)	1 day
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)	28 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)	42 days
effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)	70 days

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Jiande Chen, Ph.D, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): November 20, 2019

Study Registration Dates

• First Submitted: August 18, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (Actual): September 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: transcutaneous electroacupuncture
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Connective Tissue Diseases; Paralysis; Scleroderma, Systemic; Scleroderma, Diffuse; Gastroparesis; Scleroderma, Localized
• Other Study ID Numbers: IRB00089514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: haven't decided yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No