Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma

Gastroparesis Clinical Trial

Official title:

Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294616
• Other study ID #: IRB00089514
• Status: Completed
• Phase: N/A
• Start date: February 6, 2017
• Est. completion date: November 20, 2019

Study information

• Verified date: November 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 20, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastroparesis
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms	1 day
Primary	effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms	28 days
Primary	effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms	42 days
Primary	effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms	70 days
Primary	effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	SF-36 questionnaire will be used to assess general quality of life	1 day
Primary	effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	SF-36 questionnaire will be used to assess general quality of life	28 days
Primary	effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	SF-36 questionnaire will be used to assess general quality of life	42 days
Primary	effect of TEA on symptoms in Systemic Sclerosis (SSc) patients	SF-36 questionnaire will be used to assess general quality of life	70 days
Primary	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
Primary	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
Primary	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
Primary	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	effects of TEA on gastric motility	visit 1 in acute phase; gastric slow waves recording	1 week
Secondary	effects of TEA on gastric motility	visit 2 in acute phase; gastric slow waves recording	2 weeks
Secondary	effects of TEA on gastric motility	visit 3 in acute phase; gastric slow waves recording	3 weeks
Secondary	effects of TEA on gastric motility	visit 4 in acute phase; gastric slow waves recording	4 weeks
Secondary	effects of TEA on autonomic function	visit 1 in acute phase; heart rate variability recording	1 week
Secondary	effects of TEA on autonomic function	visit 2 in acute phase; heart rate variability recording	2 weeks
Secondary	effects of TEA on autonomic function	visit 3 in acute phase; heart rate variability recording	3 weeks
Secondary	effects of TEA on autonomic function	visit 4 in acute phase; heart rate variability recording	4 weeks
Secondary	effects of TEA on gastric motility	visit 1 in chronic phase; gastric slow waves recording	1 day
Secondary	effects of TEA on gastric motility	visit 2 in chronic phase; gastric slow waves recording	28 days
Secondary	effects of TEA on gastric motility	visit 3 in chronic phase; gastric slow waves recording	42 days
Secondary	effects of TEA on gastric motility	visit 4 in chronic phase; gastric slow waves recording	70 days
Secondary	effects of TEA on gastric motility	visit 1 in chronic phase; breath test will be used to assess gastric emptying	1 day
Secondary	effects of TEA on gastric motility	visit 2 in chronic phase; breath test will be used to assess gastric emptying	28 days
Secondary	effects of TEA on gastric motility	visit 3 in chronic phase; breath test will be used to assess gastric emptying	42 days
Secondary	effects of TEA on gastric motility	visit 4 in chronic phase; breath test will be used to assess gastric emptying	70 days
Secondary	effects of TEA on autonomic function	visit 1 in chronic phase; heart rate variability recording	1 day
Secondary	effects of TEA on autonomic function	visit 2 in chronic phase; heart rate variability recording	28 days
Secondary	effects of TEA on autonomic function	visit 3 in chronic phase; heart rate variability recording	42 days
Secondary	effects of TEA on autonomic function	visit 4 in chronic phase; heart rate variability recording	70 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	effects of TEA on autonomic function	baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.	1 day
Secondary	effects of TEA on autonomic function	baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.	28 days
Secondary	effects of TEA on autonomic function	baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.	42 days
Secondary	effects of TEA on autonomic function	baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.	70 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; vasoactive intestinal peptide (VIP)	1 day
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; vasoactive intestinal peptide (VIP)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; vasoactive intestinal peptide (VIP)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; vasoactive intestinal peptide (VIP)	70 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; vasoactive intestinal peptide (VIP)	1 day
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; vasoactive intestinal peptide (VIP)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; vasoactive intestinal peptide (VIP)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; vasoactive intestinal peptide (VIP)	70 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; vasoactive intestinal peptide (VIP)	1 day
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; vasoactive intestinal peptide (VIP)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; vasoactive intestinal peptide (VIP)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; vasoactive intestinal peptide (VIP)	70 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-10 (IL-10)	day 1
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-10 (IL-10)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-10 (IL-10)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-10 (IL-10)	70 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-10 (IL-10)	1 day
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-10 (IL-10)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-10 (IL-10)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-10 (IL-10)	70 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-10 (IL-10)	1 day
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-10 (IL-10)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-10 (IL-10)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-10 (IL-10)	70 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interferon a(IFNa)	1 day
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interferon a(IFNa)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interferon a(IFNa)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interferon a(IFNa)	70 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interferon a(IFNa)	1 day
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interferon a(IFNa)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interferon a(IFNa)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interferon a(IFNa)	70 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interferon a(IFNa)	1 day
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interferon a(IFNa)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interferon a(IFNa)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interferon a(IFNa)	70 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-1 beta (IL-1ß)	1 day
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-1 beta (IL-1ß)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-1 beta (IL-1ß)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-1 beta (IL-1ß)	70 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-1 beta (IL-1ß)	1 day
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-1 beta (IL-1ß)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-1 beta (IL-1ß)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-1 beta (IL-1ß)	70 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-1 beta (IL-1ß)	1 day
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-1 beta (IL-1ß)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-1 beta (IL-1ß)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-1 beta (IL-1ß)	70 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-6 (IL-6)	1 day
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-6 (IL-6)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-6 (IL-6)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; interleukin-6 (IL-6)	70 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-6 (IL-6)	1 day
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-6 (IL-6)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-6 (IL-6)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; interleukin-6 (IL-6)	70 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-6 (IL-6)	1 day
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-6 (IL-6)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-6 (IL-6)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; interleukin-6 (IL-6)	70 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; tumor necrosis factor alpha(TNFa)	day 1
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; tumor necrosis factor alpha(TNFa)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; tumor necrosis factor alpha(TNFa)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	baseline before the study; tumor necrosis factor alpha(TNFa)	70 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; tumor necrosis factor alpha(TNFa)	1 day
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; tumor necrosis factor alpha(TNFa)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; tumor necrosis factor alpha(TNFa)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	30 minutes after the testing meal; tumor necrosis factor alpha(TNFa)	70 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; tumor necrosis factor alpha(TNFa)	1 day
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; tumor necrosis factor alpha(TNFa)	28 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; tumor necrosis factor alpha(TNFa)	42 days
Secondary	effects of TEA on GI hormones and inflammatory cytokine	60 minutes after the testing meal; tumor necrosis factor alpha(TNFa)	70 days