Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
NCT Number: NCT03294616
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 .
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21224, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
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
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
Time frame: 1 day
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
Time frame: 28 days
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
Time frame: 42 days
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
Time frame: 70 days
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
Time frame: 1 day
SF-36 questionnaire will be used to assess general quality of life
Time frame: 28 days
SF-36 questionnaire will be used to assess general quality of life
Time frame: 42 days
SF-36 questionnaire will be used to assess general quality of life
Time frame: 70 days
SF-36 questionnaire will be used to assess general quality of life
Time frame: 1 day
a validated method including 9 symptoms will be used to assess GI symptoms
Time frame: 28 days
a validated method including 9 symptoms will be used to assess GI symptoms
Time frame: 42 days
a validated method including 9 symptoms will be used to assess GI symptoms
Time frame: 70 days
a validated method including 9 symptoms will be used to assess GI symptoms
Time frame: 1 week
visit 1 in acute phase; gastric slow waves recording
Time frame: 2 weeks
visit 2 in acute phase; gastric slow waves recording
Time frame: 3 weeks
visit 3 in acute phase; gastric slow waves recording
Time frame: 4 weeks
visit 4 in acute phase; gastric slow waves recording
Time frame: 1 week
visit 1 in acute phase; heart rate variability recording
Time frame: 2 weeks
visit 2 in acute phase; heart rate variability recording
Time frame: 3 weeks
visit 3 in acute phase; heart rate variability recording
Time frame: 4 weeks
visit 4 in acute phase; heart rate variability recording
Time frame: 1 day
visit 1 in chronic phase; gastric slow waves recording
Time frame: 28 days
visit 2 in chronic phase; gastric slow waves recording
Time frame: 42 days
visit 3 in chronic phase; gastric slow waves recording
Time frame: 70 days
visit 4 in chronic phase; gastric slow waves recording
Time frame: 1 day
visit 1 in chronic phase; breath test will be used to assess gastric emptying
Time frame: 28 days
visit 2 in chronic phase; breath test will be used to assess gastric emptying
Time frame: 42 days
visit 3 in chronic phase; breath test will be used to assess gastric emptying
Time frame: 70 days
visit 4 in chronic phase; breath test will be used to assess gastric emptying
Time frame: 1 day
visit 1 in chronic phase; heart rate variability recording
Time frame: 28 days
visit 2 in chronic phase; heart rate variability recording
Time frame: 42 days
visit 3 in chronic phase; heart rate variability recording
Time frame: 70 days
visit 4 in chronic phase; heart rate variability recording
Time frame: 1 day
visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess 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
Time frame: 42 days
visit 3 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess 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
Time frame: 1 day
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 28 days
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 42 days
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 70 days
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 1 day
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 28 days
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 42 days
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 70 days
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 1 day
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 28 days
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 42 days
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 70 days
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 1 day
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time frame: 28 days
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time frame: 42 days
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time frame: 70 days
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA 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.
Time frame: 28 days
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA 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.
Time frame: 70 days
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA 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.
Time frame: 28 days
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA 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.
Time frame: 70 days
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time frame: 1 day
baseline before the study; vasoactive intestinal peptide (VIP)
Time frame: 28 days
baseline before the study; vasoactive intestinal peptide (VIP)
Time frame: 42 days
baseline before the study; vasoactive intestinal peptide (VIP)
Time frame: 70 days
baseline before the study; vasoactive intestinal peptide (VIP)
Time frame: 1 day
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time frame: 28 days
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time frame: 42 days
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time frame: 70 days
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time frame: 1 day
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time frame: 28 days
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time frame: 42 days
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time frame: 70 days
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time frame: day 1
baseline before the study; interleukin-10 (IL-10)
Time frame: 28 days
baseline before the study; interleukin-10 (IL-10)
Time frame: 42 days
baseline before the study; interleukin-10 (IL-10)
Time frame: 70 days
baseline before the study; interleukin-10 (IL-10)
Time frame: 1 day
30 minutes after the testing meal; interleukin-10 (IL-10)
Time frame: 28 days
30 minutes after the testing meal; interleukin-10 (IL-10)
Time frame: 42 days
30 minutes after the testing meal; interleukin-10 (IL-10)
Time frame: 70 days
30 minutes after the testing meal; interleukin-10 (IL-10)
Time frame: 1 day
60 minutes after the testing meal; interleukin-10 (IL-10)
Time frame: 28 days
60 minutes after the testing meal; interleukin-10 (IL-10)
Time frame: 42 days
60 minutes after the testing meal; interleukin-10 (IL-10)
Time frame: 70 days
60 minutes after the testing meal; interleukin-10 (IL-10)
Time frame: 1 day
baseline before the study; interferon α(IFNα)
Time frame: 28 days
baseline before the study; interferon α(IFNα)
Time frame: 42 days
baseline before the study; interferon α(IFNα)
Time frame: 70 days
baseline before the study; interferon α(IFNα)
Time frame: 1 day
30 minutes after the testing meal; interferon α(IFNα)
Time frame: 28 days
30 minutes after the testing meal; interferon α(IFNα)
Time frame: 42 days
30 minutes after the testing meal; interferon α(IFNα)
Time frame: 70 days
30 minutes after the testing meal; interferon α(IFNα)
Time frame: 1 day
60 minutes after the testing meal; interferon α(IFNα)
Time frame: 28 days
60 minutes after the testing meal; interferon α(IFNα)
Time frame: 42 days
60 minutes after the testing meal; interferon α(IFNα)
Time frame: 70 days
60 minutes after the testing meal; interferon α(IFNα)
Time frame: 1 day
baseline before the study; interleukin-1 beta (IL-1β)
Time frame: 28 days
baseline before the study; interleukin-1 beta (IL-1β)
Time frame: 42 days
baseline before the study; interleukin-1 beta (IL-1β)
Time frame: 70 days
baseline before the study; interleukin-1 beta (IL-1β)
Time frame: 1 day
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time frame: 28 days
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time frame: 42 days
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time frame: 70 days
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time frame: 1 day
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time frame: 28 days
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time frame: 42 days
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time frame: 70 days
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time frame: 1 day
baseline before the study; interleukin-6 (IL-6)
Time frame: 28 days
baseline before the study; interleukin-6 (IL-6)
Time frame: 42 days
baseline before the study; interleukin-6 (IL-6)
Time frame: 70 days
baseline before the study; interleukin-6 (IL-6)
Time frame: 1 day
30 minutes after the testing meal; interleukin-6 (IL-6)
Time frame: 28 days
30 minutes after the testing meal; interleukin-6 (IL-6)
Time frame: 42 days
30 minutes after the testing meal; interleukin-6 (IL-6)
Time frame: 70 days
30 minutes after the testing meal; interleukin-6 (IL-6)
Time frame: 1 day
60 minutes after the testing meal; interleukin-6 (IL-6)
Time frame: 28 days
60 minutes after the testing meal; interleukin-6 (IL-6)
Time frame: 42 days
60 minutes after the testing meal; interleukin-6 (IL-6)
Time frame: 70 days
60 minutes after the testing meal; interleukin-6 (IL-6)
Time frame: day 1
baseline before the study; tumor necrosis factor alpha(TNFα)
Time frame: 28 days
baseline before the study; tumor necrosis factor alpha(TNFα)
Time frame: 42 days
baseline before the study; tumor necrosis factor alpha(TNFα)
Time frame: 70 days
baseline before the study; tumor necrosis factor alpha(TNFα)
Time frame: 1 day
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time frame: 28 days
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time frame: 42 days
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time frame: 70 days
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time frame: 1 day
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time frame: 28 days
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time frame: 42 days
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time frame: 70 days
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Johns Hopkins University
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