Healthy VolunteersNCT06361381
The Combined Effect of TENS and TaVNS on Pressure and Heat Pain Thresholds in Pain-Free Subjects
A study testing Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) and Transcutaneous Electrical Nerve Stimulation in people with Healthy Volunteers, run by University of Hartford at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) and Transcutaneous Electrical Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 20 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Absence of pain
- Age 18-40
- Men and women
Who cannot join
- Neurological diseases
- Severe cardiorespiratory disease
- Pregnancy
- Skin infection or lesions or change in sensation at the TENS or TaVNS application site
- Cancer
- Cardiac pacemaker
Show all 9Show fewer
- Allergy to electrodes
- Chronic illness or pain
- Use of drugs that affect pain or vagal tone in the past 48 hours prior to data collection
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hartford
West Hartford, Connecticut, 06117
About this study
Official title: The Combined Effect of Transcutaneous Electrical Nerve Stimulation and Transcutaneous Auricular Vagus Nerve Stimulation on Pressure and Heat Pain Thresholds in Pain-Free Subjects: A Randomized Cross-Over Trial
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 minutes after a baseline measurement of outcomes. TENS and TaVNS will then be turned off, but the electrodes will remain on until completion of post-treatment assessment. Pressure pain threshold, heat pain threshold, blood pressure, oxygen saturation and heart rate will be tested 4 times: Once pre-intervention, once during intervention, once immediately after the intervention and once 15 minutes post-intervention.
Read the detailed description
The study will be a simple crossover design with the following two treatments: (1) active TaVNS and (2) placebo TaVNS. Each subject will receive both interventions in random order.
Pressure and Heat pain thresholds will be recorded at baseline, 15 min, 30 min, and 45 min.
- Conditions
- Healthy Volunteers
- Being tested
- Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS), Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS), Transcutaneous Electrical Nerve Stimulation
- Keywords
- Transcutaneous Electric Nerve Stimulation, Transcutaneous Auricular Vagus Nerve Stimulation, Randomized cross-over trial, Pain Measurement, Pain Threshold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)Device
Also called TaVNS
Both concha will be swabbed with an alcohol wipe before applying a thin layer of conductive gel. An ear clip electrode will be placed in the concha of both ears.
A frequency of 25 Hz will be applied with a pulse duration of 200 µs. Every 5 minutes, the subject will be asked if the intensity can be increased, decreased or remain the same to maintain the same level of intensity. Participants will also receive active TENS, 100 Hz, 200 µsec on forearm.
Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)Device
Also called Placebo TaVNS
For placebo TaVNS, the intensity will be increased to a sensory level and then decreased to 0 mA. Participants will also receive active TENS, 100 Hz, 200 µsec on forearm.
Transcutaneous Electrical Nerve StimulationDevice
Also called TENS
TENS will be applied on subject's forearm at a strong but comfortable intensity
| Study group | Role | What they receive |
|---|---|---|
| Active TaVNS | Experimental | Active TaVNS: frequency of 25 Hz, pulse duration of 200 µs, at a strong but comfortable intensity. Receives: Device: Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS); Device: Transcutaneous Electrical Nerve Stimulation |
| Placebo TaVNS | Placebo comparator | Placebo TaVNS: the intensity will be increased to a sensory level and then decreased to 0 mA Receives: Device: Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS); Device: Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold
A digital pressure algometer will measure the pain threshold to deep mechanical stimuli in kPa
Measured: 2 weeks
Secondary outcomes (4)
Heat Pain Threshold
Superficial heat pain sensitivity, in degree Celsius, will be assessed using a handheld thermode.
Measured: 2 weeks
Heart rate
Heart rate (beats per minute) will be assessed using a fingertip pulse oximeter
Measured: 2 weeks
Oxygen saturation
Oxygen saturation in percentage will be assessed using a fingertip pulse oximeter
Measured: 2 weeks
Blood pressure
Systolic and Diastolic Blood pressure in millimeters of mercury will be assessed using a upper arm cuff, blood pressure monitor
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Apr 2024
- Primary completion20 Jul 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hartford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Liebano, University of Hartford
- Investigators
- Richard E Liebano, PhD, Principal investigator, University of Hartford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361381
- Sponsor's protocol ID
- 24-01-281
- Status last verified
- Dec 2024
- First submitted
- 25 Mar 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Liebano RE, Awad N, Bellino C, Bray K, Rosentrater H, Roy J, Tate C. The combined effect of transcutaneous electrical nerve stimulation and transcutaneous auricular vagus nerve stimulation on pressure and heat pain thresholds in pain-free subjects: a randomized cross-over trial. Trials. 2024 Jul 31;25(1):516. doi: 10.1186/s13063-024-08352-x.
PubMed 39085951
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Effect of Transcutaneous Electrical Nerve Stimulation and Transcutaneous Auricular Vagus Nerve Stimulation on Pressure and Heat Pain Thresholds in Pain-Free Subjects: A Randomized Cross-Over Trial
- ClinicalTrials.gov ID
- NCT06361381
- Acronym / sponsor ID
- 24-01-281
- Conditions
- Healthy Volunteers
- Keywords
- Transcutaneous Electric Nerve Stimulation, Transcutaneous Auricular Vagus Nerve Stimulation, Randomized cross-over trial, Pain Measurement, Pain Threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of HartfordUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 minutes after a baseline measurement of outcomes. TENS and TaVNS will then be turned off, but the electrodes will remain on until completion of post-treatment assessment. Pressure pain threshold, heat pain threshold, blood pressure, oxygen saturation and heart rate will be tested 4 times: Once pre-intervention, once during intervention, once immediately after the intervention and once 15 minutes post-intervention.
Detailed description
The study will be a simple crossover design with the following two treatments: (1) active TaVNS and (2) placebo TaVNS. Each subject will receive both interventions in random order.
Pressure and Heat pain thresholds will be recorded at baseline, 15 min, 30 min, and 45 min.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TaVNS | Experimental | Device: Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS), Device: Transcutaneous Electrical Nerve StimulationActive TaVNS: frequency of 25 Hz, pulse duration of 200 µs, at a strong but comfortable intensity. |
| Placebo TaVNS | Placebo comparator | Device: Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS), Device: Transcutaneous Electrical Nerve StimulationPlacebo TaVNS: the intensity will be increased to a sensory level and then decreased to 0 mA |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Absence of pain
- Age 18-40
- Men and women
Key exclusion criteria (9 listed)
- Neurological diseases
- Severe cardiorespiratory disease
- Pregnancy
- Skin infection or lesions or change in sensation at the TENS or TaVNS application site
- Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)Also: TaVNSBoth concha will be swabbed with an alcohol wipe before applying a thin layer of conductive gel. An ear clip electrode will be placed in the concha of both ears. A frequency of 25 Hz will be applied with a pulse duration of 200 µs. Every 5 minutes, the subject will be asked if the intensity can be increased, decreased or remain the same to maintain the same level of intensity. Participants will also receive active TENS, 100 Hz, 200 µsec on forearm. | Device | Active TaVNS |
| Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)Also: Placebo TaVNSFor placebo TaVNS, the intensity will be increased to a sensory level and then decreased to 0 mA. Participants will also receive active TENS, 100 Hz, 200 µsec on forearm. | Device | Placebo TaVNS |
| Transcutaneous Electrical Nerve StimulationAlso: TENSTENS will be applied on subject's forearm at a strong but comfortable intensity | Device | Active TaVNS, Placebo TaVNS |
Primary outcome
Pressure Pain Threshold
Time frame: 2 weeks
A digital pressure algometer will measure the pain threshold to deep mechanical stimuli in kPa
4 secondary outcomes
Heat Pain Threshold
Time frame: 2 weeks
Heart rate
Time frame: 2 weeks
Oxygen saturation
Time frame: 2 weeks
Blood pressure
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Derived from this study: PubMed 39085951Liebano RE, Awad N, Bellino C, Bray K, Rosentrater H, Roy J, Tate C. The combined effect of transcutaneous electrical nerve stimulation and transcutaneous auricular vagus nerve stimulation on pressure and heat pain thresholds in pain-free subjects: a randomized cross-over trial. Trials. 2024 Jul 31;25(1):516. doi: 10.1186/s13063-024-08352-x.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard E Liebano, PhD principal investigator
University of Hartford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) and Transcutaneous Electrical Nerve Stimulation in people with Healthy Volunteers, run by University of Hartford at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Threshold (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06361381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.