Healthy VolunteerNCT05215756
The Accuracy and Efficacy of AI-driven tVNS Algorithm
A study testing transcutaneous vagal nerve stimulation in people with Healthy Volunteer, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
Pain, including somatic and visceral pain, is a common symptom. Persistent pain can lead to repetitive visits to hospitals and can limit patients' daily activities, which can result in tremendous medical cost and lower quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- transcutaneous vagal nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2024to 30 Nov 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants (defined as those without pre-existing medical comorbidity that makes them take medications or go to hospitals regularly), aged 18-65, from staff, students and the local population of Queen Mary, University of London
Who cannot join
- Participants unable to provide informed consent
- Participants with any systemic disease or medications that may influence the autonomic nervous system (e.g. beta-agonists or Parkinson's disease)
- Pregnant or breastfeeding females
- History of drug or alcohol abuse
- Participants who have cardiovascular condition problems or epilepsy
- Participants with cochlear implants
- Participants who are using pain killers
- Not meeting any of the inclusion criteria above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proof of Concept Assessment of the Performance of Artificial Intelligence-driven Transcutaneous Vagal Nerve Stimulation (tVNS) Algorithm for Somatic Pain
Pain, including somatic and visceral pain, is a common symptom. Persistent pain can lead to repetitive visits to hospitals and can limit patients' daily activities, which can result in tremendous medical cost and lower quality of life. For example, the prevalence rates of 25% are reported only for abdominal pain among adults (3), and it costs $10.2 billion each year in the US.
Pain is usually treated according to the World Health Organisation (WHO) 3 steps analgesic ladder. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are mainly used in step 1, which can cause serious side effects such as GI bleeding, renal failure and cardiovascular disease. In step 2 \& 3, opioids are used and are also associated with serious side effects (e.g., psychological addiction, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression). Therefore, a new effective non-pharmacological treatment is beneficial for patients.
Read more
One such method is transcutaneous vagal nerve stimulation (tVNS). The auricular or cervical branch of the vagal nerve runs just under the skin and can be electrically stimulated through the skin by tVNS devices, which have shown the analgesic effects on various pain conditions.
The autonomic activity, including parasympathetic tone, can be estimated from the beat to beat intervals in the electrocardiogram, which is called heart rate variability (HRV). To date, we have shown that visceral and somatic pain triggered the autonomic response with the change in HRV, and HRV could be a biomarker of pain.
We hypothesised that the development of pain, including somatic pain and visceral pain, could be predicted by analysing heart rate pattern by artificial intelligence (AI). In this proof of concept study, we evaluate the detection rate of pain by the AI analysis of heart rate pattern. We also evaluate the effect of tVNS on the pain threshold.
Read the detailed description
Participants will be asked to attend our institution to complete an informed written consent sheet. They are asked to refrain from smoking for 12 hours and drinking alcohol and coffee as well as using recreational drugs for 48 hours prior to the study visit. After filling out a consent form, they will be asked to complete questionnaires to assess their psychological/personality status. Baseline heart rate will be measured for 10 minutes using a heart recording device. After the baseline measurement, the cold pressor test starts. Participants will be asked to immerse their hand into an ice water container. Then, the cold pain threshold and cold pain tolerance will be measured. During the cold pressor test, we will keep recording heart rate. We'll see if we can detect a change of heart rate variability (HRV) in response to pain.
After 10 minutes break, the cold pressor test will be performed again. This time, tVNS is administered for 2 minutes during the cold pressor test. We will evaluate the changes in cold pain threshold and cold pain tolerance along the course.
Finally, after 10 minutes interval, participants will be asked to exercise in the room (static jogging for 1 minute) to increase their heart rate. Then, the cold pressor test will be performed again. We will evaluate if we can detect a change of HRV in the circumstance where the heart rate increases. tVNS will also be administered for 2 minutes.
- Conditions
- Healthy Volunteer
- Being tested
- transcutaneous vagal nerve stimulation
- Keywords
- transcutaneous vagal nerve stimulation, heart rate variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous vagal nerve stimulationDevice
The tVNS device will be attached to the left concha of the ear to stimulate the auricular branch of the vagal nerve. Each stimulation will last for 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Experimental | Cold pressor test will be performed 3 times. transcutaneous Vagal nerve stimulation will be administered in the 2nd and 3rd cold pressor tests. Receives: Device: transcutaneous vagal nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection rate of HRV change in response to pain
The ratio of successful detection of HRV changes in response to pain (cold pressor test) among 20 subjects
Measured: 1 hour
The detection rate of HRV change in response to pain after exercising
The ratio of successful detection of HRV changes in response to pain (cold pressor test) among 20 subjects with increased heart rate by exercising
Measured: 1 hour
Secondary outcomes (4)
Changes in the threshold and tolerance of pain before and after tVNS
Cold pain threshold is defined as the time between the start of immersing and the first report of pain. Cold pain tolerance is defined as the time between the first report of pain and the removal of the hand from the water. We will evaluate changes in the threshold and tolerance before and after tVNS.
Measured: 1 hour
Psychological questionnaire scores
State and Trait Anxiety Inventory state, trait (Maximum and minimum values are 80 and 20, respectively. The higher value indicates more nervous status) is used.
Measured: 1 hour
Personality questionnaire scores
Big five inventory questionnaire (44 items) is used. This is a self-report inventory designed to measure the personality type.
Measured: 1 hour
Anxiety and depression questionnaire scores
Hospital Anxiety and Depression Scale is used. The maximun and minimum values are 21 and 0, respectively (0-7 = Normal, 8-10 = Borderline,11-21 = Abnormal).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Apr 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cross-sectional study
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215756
- Sponsor's protocol ID
- QMERC2020/56
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2022
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Assessment of the Performance of Artificial Intelligence-driven Transcutaneous Vagal Nerve Stimulation (tVNS) Algorithm for Somatic Pain
- ClinicalTrials.gov ID
- NCT05215756
- Acronym / sponsor ID
- QMERC2020/56
- Conditions
- Healthy Volunteer
- Keywords
- transcutaneous vagal nerve stimulation, heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 31 Jan 2022 (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.
Pain, including somatic and visceral pain, is a common symptom. Persistent pain can lead to repetitive visits to hospitals and can limit patients' daily activities, which can result in tremendous medical cost and lower quality of life. For example, the prevalence rates of 25% are reported only for abdominal pain among adults (3), and it costs $10.2 billion each year in the US.
Pain is usually treated according to the World Health Organisation (WHO) 3 steps analgesic ladder. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are mainly used in step 1, which can cause serious side effects such as GI bleeding, renal failure and cardiovascular disease. In step 2 \& 3, opioids are used and are also associated with serious side effects (e.g., psychological addiction, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression). Therefore, a new effective non-pharmacological treatment is beneficial for patients.
One such method is transcutaneous vagal nerve stimulation (tVNS). The auricular or cervical branch of the vagal nerve runs just under the skin and can be electrically stimulated through the skin by tVNS devices, which have shown the analgesic effects on various pain conditions.
The autonomic activity, including parasympathetic tone, can be estimated from the beat to beat intervals in the electrocardiogram, which is called heart rate variability (HRV). To date, we have shown that visceral and somatic pain triggered the autonomic response with the change in HRV, and HRV could be a biomarker of pain.
We hypothesised that the development of pain, including somatic pain and visceral pain, could be predicted by analysing heart rate pattern by artificial intelligence (AI). In this proof of concept study, we evaluate the detection rate of pain by the AI analysis of heart rate pattern. We also evaluate the effect of tVNS on the pain threshold.
Detailed description
Participants will be asked to attend our institution to complete an informed written consent sheet. They are asked to refrain from smoking for 12 hours and drinking alcohol and coffee as well as using recreational drugs for 48 hours prior to the study visit. After filling out a consent form, they will be asked to complete questionnaires to assess their psychological/personality status. Baseline heart rate will be measured for 10 minutes using a heart recording device. After the baseline measurement, the cold pressor test starts. Participants will be asked to immerse their hand into an ice water container. Then, the cold pain threshold and cold pain tolerance will be measured. During the cold pressor test, we will keep recording heart rate. We'll see if we can detect a change of heart rate variability (HRV) in response to pain.
After 10 minutes break, the cold pressor test will be performed again. This time, tVNS is administered for 2 minutes during the cold pressor test. We will evaluate the changes in cold pain threshold and cold pain tolerance along the course.
Finally, after 10 minutes interval, participants will be asked to exercise in the room (static jogging for 1 minute) to increase their heart rate. Then, the cold pressor test will be performed again. We will evaluate if we can detect a change of HRV in the circumstance where the heart rate increases. tVNS will also be administered for 2 minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross-sectional study
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Experimental | Device: transcutaneous vagal nerve stimulationCold pressor test will be performed 3 times. transcutaneous Vagal nerve stimulation will be administered in the 2nd and 3rd cold pressor tests. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy participants (defined as those without pre-existing medical comorbidity that makes them take medications or go to hospitals regularly), aged 18-65, from staff, students and the local population of Queen Mary, University of London
Key exclusion criteria (8 listed)
- Participants unable to provide informed consent
- Participants with any systemic disease or medications that may influence the autonomic nervous system (e.g. beta-agonists or Parkinson's disease)
- Pregnant or breastfeeding females
- History of drug or alcohol abuse
- Participants who have cardiovascular condition problems or epilepsy
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 |
|---|---|---|
| transcutaneous vagal nerve stimulationThe tVNS device will be attached to the left concha of the ear to stimulate the auricular branch of the vagal nerve. Each stimulation will last for 2 minutes. | Device | Healthy Subjects |
Primary outcome
The detection rate of HRV change in response to pain
Time frame: 1 hour
The ratio of successful detection of HRV changes in response to pain (cold pressor test) among 20 subjects
The detection rate of HRV change in response to pain after exercising
Time frame: 1 hour
The ratio of successful detection of HRV changes in response to pain (cold pressor test) among 20 subjects with increased heart rate by exercising
4 secondary outcomes
Changes in the threshold and tolerance of pain before and after tVNS
Time frame: 1 hour
Psychological questionnaire scores
Time frame: 1 hour
Personality questionnaire scores
Time frame: 1 hour
Anxiety and depression questionnaire scores
Time frame: 1 hour
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 7 Jan 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous vagal nerve stimulation in people with Healthy Volunteer, run by Queen Mary University of London at 1 site in United Kingdom.
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 1 inclusion and 8 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 7 Jan 2025. 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 Kingdom. 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. 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?
The detection rate of HRV change in response to pain (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 7 Jan 2025.