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NCT06361381 · ClinicalTrials.gov registry record · NA
The Combined Effect of TENS and TaVNS on Pressure and Heat Pain Thresholds in Pain-Free Subjects
A NA study, sponsored by University of Hartford.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT06361381: Completed NA study, sponsored by University of Hartford.
NCT06361381 is a NA study that has completed, run by University of Hartford. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06361381, a NA study, has completed, sponsored by University of Hartford.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive modality that utilizes electrical currents to modulate pain in populations with acute and chronic pain. TENS has been demonstrated to produce hypoalgesic effects in postoperative pain, fibromyalgia, knee osteoarthritis, and healthy subjects. Transcutaneous auricular vagus nerve stimulation (TaVNS) is a non-invasive modality that modulates the vagus nerve by stimulating its auricular branches. The effects of the combination of TENS and TaVNS on producing an analgesic response have not been studied. Considering that TENS and TaVNS both stimulate similar analgesic pathways but through different means of activation, the investigators can hypothesize that a combination of both methods can produce a more pronounced analgesic response. Therefore, the objective of this study is to assess the hypoalgesic effect of a combination of TENS and TaVNS in pain-free subjects. The study will be a simple crossover design conducted at the University of Hartford. Subjects will be recruited from the University of Hartford population via oral communication, digital flyers, and posters on campus. Thirty participants will undergo two sessions in a crossover manner with one week in between. During one session, the participants will receive TENS with active TaVNS and the other session will be a placebo procedure (TENS with placebo TaVNS). The order of these sessions will be randomized. Importantly, the pressure pain threshold (PPT) and heat pain threshold (HPT) assessors will be blinded to the treatment category. For active TaVNS, a frequency of 25 Hz will be applied with a pulse duration of 200 µs. For placebo TaVNS, the intensity will be increased to a sensory level and then decreased to 0 mA. High frequency TENS of 100Hz will be applied in both sessions, with a pulse duration of 200 µsec, asymmetrical biphasic square waveform, and intensity of maximal tolerance without pain. TENS and TaVNS will be turned on for 30 minute
Primary Outcome
A digital pressure algometer will measure the pain threshold to deep mechanical stimuli in kPa
Interventions
- DEVICE Transcutaneous Electrical Nerve Stimulation
- DEVICE Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)
- DEVICE Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2024-10-20 |
| Phase | NA |
What the finished NCT06361381 record still lists
NCT06361381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Transcutaneous Electrical Nerve Stimulation is the first listed.
NCT06361381 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06361381 about?
NCT06361381 is a clinical study titled "The Combined Effect of TENS and TaVNS on Pressure and Heat Pain Thresholds in Pain-Free Subjects". Transcutaneous electrical nerve stimulation (TENS) is a non-invasive modality that utilizes electrical currents to modulate pain in populations with acute and chronic pain. TENS has been demonstrated to produce hypoalgesic effects in postoperative pain, fibromyalgia, knee osteoarthritis, and healthy...
What is the current status of trial NCT06361381?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2024-04-01. Estimated completion is 2024-10-20.
What interventions are being tested in trial NCT06361381?
The interventions under investigation include: Transcutaneous Electrical Nerve Stimulation (DEVICE), Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) (DEVICE), Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) (DEVICE).
Who is sponsoring clinical trial NCT06361381?
This trial is sponsored by University of Hartford, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06361381's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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