Trial Outcomes & Findings for TENS in Scleroderma (NCT NCT06646913)
NCT ID: NCT06646913
Last Updated: 2026-08-13
Results Overview
Acceptability of the TENS device as demonstrated by: 1. Subjects who are able to complete the trial by reaching the end of the testing period with the device 2. Subjects who utilize the device for at least 80% of the proposed applications.
COMPLETED
NA
11 participants
4 weeks
2026-08-13
Participant Flow
Participant milestones
| Measure |
Scleroderma Patients With Gastroparesis Symptoms
Transcutaneous Electrical Nerve Stimulation Patients utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Scleroderma Patients With Gastroparesis Symptoms
Transcutaneous Electrical Nerve Stimulation Patients utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.
|
|---|---|
|
Overall Study
Failure of the device
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Although 11 participants started the study, only 10 completed the baseline UCLA GIT 2.0 questionnaire and were included in this baseline analysis.
Baseline characteristics by cohort
| Measure |
Scleroderma Patients With Gastroparesis Symptoms
n=11 Participants
Transcutaneous Electrical Nerve Stimulation: Patients will utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.
|
|---|---|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 9.6 • n=11 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=11 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=11 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
|
Marital Status
Single
|
4 Participants
n=11 Participants
|
|
Marital Status
Married
|
5 Participants
n=11 Participants
|
|
Marital Status
Unknown
|
2 Participants
n=11 Participants
|
|
Height (cm)
|
163.3 cm
STANDARD_DEVIATION 4.3 • n=11 Participants
|
|
Weight (kg)
|
74.8 kg
STANDARD_DEVIATION 16.3 • n=11 Participants
|
|
Body Mass Index (BMI)
|
28.1 kg/m^2
STANDARD_DEVIATION 6.1 • n=11 Participants
|
|
UCLA-Gastrointestinal Tract (GIT) 2.0 Scores
ULCA GIT Total Score
|
0.8 units on a scale
STANDARD_DEVIATION 0.4 • n=10 Participants • Although 11 participants started the study, only 10 completed the baseline UCLA GIT 2.0 questionnaire and were included in this baseline analysis.
|
|
UCLA-Gastrointestinal Tract (GIT) 2.0 Scores
Distension Score
|
1.5 units on a scale
STANDARD_DEVIATION 0.6 • n=10 Participants • Although 11 participants started the study, only 10 completed the baseline UCLA GIT 2.0 questionnaire and were included in this baseline analysis.
|
|
Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) Scores
GCSI-DD Total
|
1.1 units on a scale
STANDARD_DEVIATION 0.7 • n=10 Participants • Although 11 participants started the study, only 10 completed the baseline Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) questionnaire and were included in this baseline analysis.
|
|
Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) Scores
GCSI-DD Bloating
|
1.4 units on a scale
STANDARD_DEVIATION 0.7 • n=10 Participants • Although 11 participants started the study, only 10 completed the baseline Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) questionnaire and were included in this baseline analysis.
|
|
Baseline Gastric Motility Status
Delayed liquid and solid phases
|
3 Participants
n=11 Participants
|
|
Baseline Gastric Motility Status
Delayed liquid phase only
|
2 Participants
n=11 Participants
|
|
Baseline Gastric Motility Status
Delayed solid phase only
|
3 Participants
n=11 Participants
|
|
Baseline Gastric Motility Status
Normal
|
3 Participants
n=11 Participants
|
PRIMARY outcome
Timeframe: 4 weeksAcceptability of the TENS device as demonstrated by: 1. Subjects who are able to complete the trial by reaching the end of the testing period with the device 2. Subjects who utilize the device for at least 80% of the proposed applications.
Outcome measures
| Measure |
Scleroderma Patients With Gastroparesis Symptoms
n=11 Participants
Transcutaneous Electrical Nerve Stimulation Patients utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.
|
|---|---|
|
Acceptability of the TENS Device
Subjects who are able to complete the trial
|
9 Participants
|
|
Acceptability of the TENS Device
Subjects who utilize the device for at least 80% of the proposed applications.
|
9 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Nine participants were included in this analysis because calculation of change from baseline required both baseline and post-baseline assessments. Two participants had baseline data but did not complete the 4-week treatment and follow-up assessments and were therefore not evaluable for this outcome.
Mean change in the GCSI Total score (0-4 where higher score reflects greater severity)from baseline to after the TENS intervention.
Outcome measures
| Measure |
Scleroderma Patients With Gastroparesis Symptoms
n=9 Participants
Transcutaneous Electrical Nerve Stimulation Patients utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.
|
|---|---|
|
Efficacy of TENS in Treating Scleroderma-related Gastroparesis
|
-0.25 units on a scale
Interval -0.65 to 0.15
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Nine participants were included in this analysis because calculation of change from baseline required both baseline and post-baseline assessments. Two participants had baseline data but did not complete the 4-week treatment and follow-up assessments and were therefore not evaluable for this outcome.
Mean change in the ULCA-GIT 2.0 Distention/Bloating scale (0-3.0 where 0 is lowest severity and 3.0 is greatest severity) from baseline to after the TENS intervention.
Outcome measures
| Measure |
Scleroderma Patients With Gastroparesis Symptoms
n=9 Participants
Transcutaneous Electrical Nerve Stimulation Patients utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.
|
|---|---|
|
Assessment of the Effect of TENS of Gastroparesis Symptoms
|
-0.17 units on a scale
Interval -0.68 to 0.35
|
SECONDARY outcome
Timeframe: 8 weeksNumber of participants with treatment-related adverse events as assessed by CTCAE v5.0. The CTCAE v5.0 is a standardize tool to grade adverse events on a scale of 1 to 5, where 1 is "mild" grade 2 is "moderate", 3 is "severe", 4 is "life threatening", and 5 is "death". Outcome is shown as number of participants who experienced an adverse event in each possible grade.
Outcome measures
| Measure |
Scleroderma Patients With Gastroparesis Symptoms
n=11 Participants
Transcutaneous Electrical Nerve Stimulation Patients utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.
|
|---|---|
|
Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis
Grade 1
|
0 Participants
|
|
Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis
Grade 2
|
0 Participants
|
|
Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis
Grade 3
|
0 Participants
|
|
Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis
Grade 4
|
0 Participants
|
|
Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis
Grade 5
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Of the 11 participants with baseline gastric motility data, 8 had abnormal (delayed) gastric motility and were eligible for repeat assessment at Week 4. Two of these eight participants did not complete the Week 4 assessment; therefore, six participants were included in this analysis.
Participants were categorized as having "normal" or "abnormal" gastric motility at baseline. Those who were categorized as "abnormal" at baseline repeated the test at 4 weeks, after the intervention. Those who were classified as "normal" did not repeat the test.
Outcome measures
| Measure |
Scleroderma Patients With Gastroparesis Symptoms
n=6 Participants
Transcutaneous Electrical Nerve Stimulation Patients utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.
|
|---|---|
|
Gastric Motility in Participants
Delayed solids only at baseline to normal at Week 4
|
2 Participants
|
|
Gastric Motility in Participants
Delayed liquids & solids at baseline to delayed solids only at Week 4
|
2 Participants
|
|
Gastric Motility in Participants
Delayed liquids & solids at baseline to delayed liquids & solids at Week 4
|
1 Participants
|
|
Gastric Motility in Participants
Delayed liquid only at baseline to delayed liquids & solids at Week 4
|
1 Participants
|
Adverse Events
Scleroderma Patients With Gastroparesis Symptoms
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place