NCT05987813

Transcutaneous Electric Nerve Stimulation (TENS) for Vagal Modulation

Terminated NA Results posted Last updated 27 December 2024

What this trial tests

NA trial testing TENS Unit in Functional Gastrointestinal Disorders in 8 participants. Terminated before completion.

Timeline

18 October 2023

Primary endpoint
4 June 2024

4 June 2024

Quick facts

Lead sponsor	Virginia Commonwealth University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	18 October 2023
Primary completion	4 June 2024
Estimated completion	4 June 2024
Sites	1 location across United States

Drugs / interventions tested

• TENS Unit

Conditions studied

• Functional Gastrointestinal Disorders — all drugs for Functional Gastrointestinal Disorders →

Sponsor

Virginia Commonwealth University

Who can join

Adults 12 to 21, female only, with Functional Gastrointestinal Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in High-frequency Heart Rate Variability (hfHRV) at 4 Weeks Primary · 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.

Group	Value	95% CI
FGID	23.517	± 31.705
Non-FGID	11.69	± 19.644

Rate of Compliance With Daily TENS Usage Primary · 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.

Group	Value	95% CI
FGID	0.598	± 0.296
Non-FGID	0.823	± 0.211

Adverse events — posted to ClinicalTrials.gov

Time frame: Duration of study participation- 4 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

FGID

Serious: 0/5 (0%)

Deaths: 0/5

Non-FGID

Serious: 0/3 (0%)

Deaths: 0/3

Other adverse events (4 terms — click to expand)

Reaction	System	FGID	Non-FGID
Ear clip discomfort	Ear and labyrinth disorders	—	—
Ear scabbing	Ear and labyrinth disorders	—	—
Blurry vision	Eye disorders	—	—
Headache	General disorders	—	—

Data from ClinicalTrials.gov NCT05987813 adverse events section.

Sponsor's own description

This study is to determine if the auricular microstimulator produces the expected increase in HRV.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.