Pain, AcuteTVNS_TSPNCT04448990
Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation
A study testing TENS eco 2 Transauricular vagal nerve stimulation in people with Pain, Acute, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
This investigation is going to study whether electrical tVNS applied at the cymba of auricular conchae reduces central sensitization of experimentally induced pain in comparison with electrical sham stimulation applied at the earlobes and whether the hypoalgesic effects of tVNS disappear after pharmacological block of… Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- TENS eco 2 Transauricular vagal nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- May 2021to Aug 2023
- 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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers aged 18-45 years old, who have given informed consent
- at least two days free from consume of recreational drugs
- no local infection at the site of tVNS and pain stimulation
Who cannot join
- psychiatric disorders
- abnormal skin conditions (infection, scars, psoriasis, eczema) at the site of tVNS
- contra-indications for MRI (e.g. claustrophobia, pregnancy, tattoos, metallic implants)
- history of coronary heart disease, cardiac arrhythmia, glaucoma, allergy to sulphates
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medicine of Greifswald
Greifswald, 17475
Taras Usichenko, MD, PhD, taras@uni-greifswald.de
About this study
Official title: Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation and Its Underlying Mechanisms
This investigation is going to study whether electrical tVNS applied at the cymba of auricular conchae reduces central sensitization of experimentally induced pain in comparison with electrical sham stimulation applied at the earlobes and whether the hypoalgesic effects of tVNS disappear after pharmacological block of muscarinic receptors. Also, this investigation will examine whether tVNS is associated with activation in brain areas, involved in processing of thermal pain stimuli and emotional and vegetative modulation of thermal pain in subjects who will respond with antinociceptive reaction to tVNS.
- Conditions
- Pain, Acute
- Being tested
- TENS eco 2 Transauricular vagal nerve stimulation, Sham TENS eco 2
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS eco 2 Transauricular vagal nerve stimulationDevice
Auricular electrical stimulation will be applied bilaterally using Transcutaneous Electrical Nerve Stimulation device TENS eco 2 (Schwa-Medico, Pierenkemper GmbH, Ehringshausen, Germany).
tVNS will be applied bilaterally using electrical square impulses delivered in blocks of 9 impulses with a frequency of 100 Hz and a pulse width of 200 μs emitted twice per second resulting in mixed frequency pattern of 100 Hz/2 Hz with the current intensity, that will be individually adjusted for each ear separately until the maximal tVNS intensity, which is not uncomfortable or painful, will be achieved.
Sham TENS eco 2Device
Sham
| Study group | Role | What they receive |
|---|---|---|
| tVNS | Experimental | Stimulation will be applied using TENS device eco 2 (Schwa-Medico, Pierenkemper GmbH, Ehringshausen, Germany) bilaterally at the cymba conchae of the auricles for 20 minutes. Current intensity (1-max. 10 mA) will be individually adjusted for each ear separately until the maximal tVNS intensity, which is not uncomfortable or painful, will be achieved. Receives: Device: TENS eco 2 Transauricular vagal nerve stimulation |
| Sham | Sham comparator | Same stimulation will be applied using TENS device eco 2 (Schwa-Medico, Pierenkemper GmbH, Ehringshausen, Germany) to bilaterally to the earlobes for 20 minutes. Current intensity (1-max. 10 mA) will be individually adjusted for each ear separately until the maximal tVNS intensity, which is not uncomfortable or painful, will be achieved. Receives: Device: Sham TENS eco 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unpleasantness of pain
perceived unpleasantness of pain, which participants will rate continuously during the repetitive heat stimulation using a computerized visual analogue scale (CoVAS, Medoc Advanced Medical Systems, Ramat Yishai, Israel) ranging from 0 (= not unpleasant at all) to 100 (= intolerable pain).
Measured: Continuously 5 minutes during the experimental heat pain stimulation
Secondary outcomes (2)
Heart rate
Heart rate (bpm)
Measured: Continuously 5 minutes during the experimental heat pain stimulation
Blood pressure
Systolic and diastolic blood pressure
Measured: 4 times during 5 minutes of the experimental heat pain stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study startMay 2021 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two periods (real and sham tVNS) randomized crossover investigation in healthy volunteers
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448990
- Sponsor's protocol ID
- BB 196/18
- Acronym
- TVNS_TSP
- Status last verified
- Jun 2020
- First submitted
- 23 Jun 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be available of request
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation and Its Underlying Mechanisms
- ClinicalTrials.gov ID
- NCT04448990
- Acronym / sponsor ID
- TVNS_TSP / BB 196/18
- Conditions
- Pain, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 26 Jun 2020 (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.
This investigation is going to study whether electrical tVNS applied at the cymba of auricular conchae reduces central sensitization of experimentally induced pain in comparison with electrical sham stimulation applied at the earlobes and whether the hypoalgesic effects of tVNS disappear after pharmacological block of muscarinic receptors. Also, this investigation will examine whether tVNS is associated with activation in brain areas, involved in processing of thermal pain stimuli and emotional and vegetative modulation of thermal pain in subjects who will respond with antinociceptive reaction to tVNS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two periods (real and sham tVNS) randomized crossover investigation in healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| tVNS | Experimental | Device: TENS eco 2 Transauricular vagal nerve stimulationStimulation will be applied using TENS device eco 2 (Schwa-Medico, Pierenkemper GmbH, Ehringshausen, Germany) bilaterally at the cymba conchae of the auricles for 20 minutes. Current intensity (1-max. 10 mA) will be individually adjusted for each ear separately until the maximal tVNS intensity, which is not uncomfortable or painful, will be achieved. |
| Sham | Sham comparator | Device: Sham TENS eco 2Same stimulation will be applied using TENS device eco 2 (Schwa-Medico, Pierenkemper GmbH, Ehringshausen, Germany) to bilaterally to the earlobes for 20 minutes. Current intensity (1-max. 10 mA) will be individually adjusted for each ear separately until the maximal tVNS intensity, which is not uncomfortable or painful, will be achieved. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy volunteers aged 18-45 years old, who have given informed consent
- at least two days free from consume of recreational drugs
- no local infection at the site of tVNS and pain stimulation
Key exclusion criteria (4 listed)
- psychiatric disorders
- abnormal skin conditions (infection, scars, psoriasis, eczema) at the site of tVNS
- contra-indications for MRI (e.g. claustrophobia, pregnancy, tattoos, metallic implants)
- history of coronary heart disease, cardiac arrhythmia, glaucoma, allergy to sulphates
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 |
|---|---|---|
| TENS eco 2 Transauricular vagal nerve stimulationAuricular electrical stimulation will be applied bilaterally using Transcutaneous Electrical Nerve Stimulation device TENS eco 2 (Schwa-Medico, Pierenkemper GmbH, Ehringshausen, Germany). tVNS will be applied bilaterally using electrical square impulses delivered in blocks of 9 impulses with a frequency of 100 Hz and a pulse width of 200 μs emitted twice per second resulting in mixed frequency pattern of 100 Hz/2 Hz with the current intensity, that will be individually adjusted for each ear separately until the maximal tVNS intensity, which is not uncomfortable or painful, will be achieved. | Device | tVNS |
| Sham TENS eco 2Sham | Device | Sham |
Primary outcome
Unpleasantness of pain
Time frame: Continuously 5 minutes during the experimental heat pain stimulation
perceived unpleasantness of pain, which participants will rate continuously during the repetitive heat stimulation using a computerized visual analogue scale (CoVAS, Medoc Advanced Medical Systems, Ramat Yishai, Israel) ranging from 0 (= not unpleasant at all) to 100 (= intolerable pain).
2 secondary outcomes
Heart rate
Time frame: Continuously 5 minutes during the experimental heat pain stimulation
Blood pressure
Time frame: 4 times during 5 minutes of the experimental heat pain stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Individual participant dataSharing planned: Undecided. Data will be available of request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS eco 2 Transauricular vagal nerve stimulation in people with Pain, Acute, run by University Medicine Greifswald at 1 site in Germany.
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 4 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: status not confirmed, as of the sponsor's last update on 26 Jun 2020. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taras Usichenko, MD, PhD (+49 3834865893, taras@uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unpleasantness of pain (time frame: Continuously 5 minutes during the experimental heat pain stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2020.