The Accuracy and Efficacy of AI-driven tVNS Algorithm

NCT05215756 | Completed

• 1 other identifier: QMERC2020/56
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Volunteer

Keywords

transcutaneous vagal nerve stimulation; heart rate variability

Outcome Measures

Primary Outcomes (2)

• 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

  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

  1 hour

Secondary Outcomes (4)

• Changes in the threshold and tolerance of pain before and after tVNS

  1 hour

• Psychological questionnaire scores

  1 hour

• Personality questionnaire scores

  1 hour

• Anxiety and depression questionnaire scores

  1 hour

Study Arms (1)

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.

Device: transcutaneous vagal nerve stimulation

Interventions

transcutaneous vagal nerve stimulation DEVICE

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.

Healthy Subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Queen Mary University of London

London, E1 2AJ, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-sectional study

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 31, 2022
• Study Start: April 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)