Trial Outcomes & Findings for Transcutaneous Electric Nerve Stimulation (TENS) for Vagal Modulation (NCT NCT05987813)
NCT ID: NCT05987813
Last Updated: 2024-12-27
Results Overview
Determine if microstimulation over a 4 week period results in improvement in hfHRV power. Average hfHRV power was calculated at baseline and 4 weeks. The change in average hfHRV power in milliseconds squared from baseline to 4 weeks was calculated for each participant. The average change for each group is reported.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
Assessed at baseline and 4 weeks.
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
FGID
Patients with a FGID
TENS Unit: Usage of the Transcutaneous Electrical Nerve Stimulation device for 2 hours a day.
|
Non-FGID
Patients without a FGID
TENS Unit: Usage of the Transcutaneous Electrical Nerve Stimulation device for 2 hours a day.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
FGID
n=5 Participants
Patients with a FGID
TENS Unit: Usage of the Transcutaneous Electrical Nerve Stimulation device for 2 hours a day.
|
Non-FGID
n=3 Participants
Patients without a FGID
TENS Unit: Usage of the Transcutaneous Electrical Nerve Stimulation device for 2 hours a day.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
5 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
17 years
STANDARD_DEVIATION 0.707 • n=5 Participants
|
19 years
STANDARD_DEVIATION 0 • n=3 Participants
|
17.75 years
STANDARD_DEVIATION 1.165 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=3 Participants
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
3 participants
n=3 Participants
|
8 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Assessed at baseline and 4 weeks.Determine if microstimulation over a 4 week period results in improvement in hfHRV power. Average hfHRV power was calculated at baseline and 4 weeks. The change in average hfHRV power in milliseconds squared from baseline to 4 weeks was calculated for each participant. The average change for each group is reported.
Outcome measures
| Measure |
FGID
n=5 Participants
Patients with a FGID
TENS Unit: Usage of the Transcutaneous Electrical Nerve Stimulation device for 2 hours a day.
|
Non-FGID
n=3 Participants
Patients without a FGID
TENS Unit: Usage of the Transcutaneous Electrical Nerve Stimulation device for 2 hours a day.
|
|---|---|---|
|
Change in High-frequency Heart Rate Variability (hfHRV) at 4 Weeks
|
23.517 ms squared
Standard Deviation 31.705
|
11.69 ms squared
Standard Deviation 19.644
|
PRIMARY outcome
Timeframe: Assessed daily for duration of study (4 weeks) via self-report recording journal.Determine the compliance rate of adolescents utilizing a microstimulator. Compliance rate calculated as number of minutes unit was used (summed from all self-report daily recording journals) divided by 3360 (the total number of minutes the unit could have been used if the participant used it for 2 hours daily for 4 weeks). The rate average for each group is reported.
Outcome measures
| Measure |
FGID
n=5 Participants
Patients with a FGID
TENS Unit: Usage of the Transcutaneous Electrical Nerve Stimulation device for 2 hours a day.
|
Non-FGID
n=3 Participants
Patients without a FGID
TENS Unit: Usage of the Transcutaneous Electrical Nerve Stimulation device for 2 hours a day.
|
|---|---|---|
|
Rate of Compliance With Daily TENS Usage
|
0.598 percentage - compliance rate
Standard Deviation 0.296
|
0.823 percentage - compliance rate
Standard Deviation 0.211
|
Adverse Events
FGID
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Non-FGID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FGID
n=5 participants at risk
Patients with a FGID
TENS Unit: Usage of the Transcutaneous Electrical Nerve Stimulation device for 2 hours a day.
|
Non-FGID
n=3 participants at risk
Patients without a FGID
TENS Unit: Usage of the Transcutaneous Electrical Nerve Stimulation device for 2 hours a day.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear clip discomfort
|
80.0%
4/5 • Number of events 8 • Duration of study participation- 4 weeks
Participants could report AEs in a section of their Daily Recording Diary, completed virtually each day via REDCap data capture system.
|
100.0%
3/3 • Number of events 3 • Duration of study participation- 4 weeks
Participants could report AEs in a section of their Daily Recording Diary, completed virtually each day via REDCap data capture system.
|
|
Ear and labyrinth disorders
Ear scabbing
|
60.0%
3/5 • Number of events 7 • Duration of study participation- 4 weeks
Participants could report AEs in a section of their Daily Recording Diary, completed virtually each day via REDCap data capture system.
|
0.00%
0/3 • Duration of study participation- 4 weeks
Participants could report AEs in a section of their Daily Recording Diary, completed virtually each day via REDCap data capture system.
|
|
Eye disorders
Blurry vision
|
20.0%
1/5 • Number of events 1 • Duration of study participation- 4 weeks
Participants could report AEs in a section of their Daily Recording Diary, completed virtually each day via REDCap data capture system.
|
0.00%
0/3 • Duration of study participation- 4 weeks
Participants could report AEs in a section of their Daily Recording Diary, completed virtually each day via REDCap data capture system.
|
|
General disorders
Headache
|
20.0%
1/5 • Number of events 1 • Duration of study participation- 4 weeks
Participants could report AEs in a section of their Daily Recording Diary, completed virtually each day via REDCap data capture system.
|
0.00%
0/3 • Duration of study participation- 4 weeks
Participants could report AEs in a section of their Daily Recording Diary, completed virtually each day via REDCap data capture system.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place