Pain Perception and the Autonomic Nervous System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: respiratory gated taVNS, random burst stimulation, continuous stimulation, Sham stimulation.
- Who it may be relevant to
- Registry conditions: Autonomic Nervous System Modulation, Pain Perception, Pain Sensitivity, Central Sensitization. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Influences of the Autonomic Nervous System on Experimental Pain Sensitization
Overview
In this study, we want to investigate how pain processing and sensation are related to a certain part of the nervous system, the so-called autonomic nervous system. For this purpose, we apply heat and pressure stimuli to the skin and test pain processing by means of ratings scales and sensory tests. Breathing, heart rate and sweat response are also measured. To assess the spinal cord level, we measure muscle response (measured by electromyography, EMG) to electrical stimulation. Additionally, sensory nerves will be stimulated at the ear and participants will also be given various questionnaires to complete.
Detailed description
This study investigates the effects of autonomic regulation on pain perception and experimentally induced pain sensitivity. Participants come for one or two study visits, that will last approximately 3 hours. The study is divided into two phases: the pilot phase and the main experimental phase.
During the pilot phase, the perception of pressure and heat stimuli, as well as spinal excitability, will be assessed before and during different types of electrical stimulation of sensory nerves at the outer ear.
During the main experimental phase, skin sensitivity and spinal excitability will be assessed before and after repetitive heat stimulation and stimulation of sensory nerves at the outer ear.
In both study phases, the activity of the autonomic nervous system will be assessed throughout the experiment, and questionnaires will be completed.
Interventions
- Other respiratory gated taVNS
Electrical stimulation will be delivered in bursts during expiration - Other random burst stimulation
Electrical stimulation will be delivered in bursts at random timepoints during the breathing cycle - Other continuous stimulation
Electrical stimulation will be delivered continuously for 30sec followed by a 30sec break. - Other Sham stimulation
Electrical stimulation will be identical to the taVNS, but the electrodes will be placed at a different position on the ear
Primary outcome measures
- Magnitude of the Nociceptive Withdrawl Reflex [Time frame: Before, during, and/or immediately after the intervention]
Eligibility criteria
Inclusion criteria
- Over 18 and below 40 years of age
- Good general health
- Able to give informed consent
Exclusion criteria
- Any major medical or psychiatric condition (e.g. heart disease, diabetes, autoimmune disorders, infectious diseases, major depressive disorder), any chronic pain condition, any respiratory problems, any acute pain at time of study
- Inability to follow study instructions, e.g. due to language problems
- Pregnancy (female participants will be asked if pregnancy could be possible)
- Increased alcohol (\>2 (for women)/4 (for men) standard glasses per day or \>5 (for women)/4 (for men) glasses at least once a month within a few hours) or caffeine consumption (≥ 400mg per day)
- Consumption of alcohol, drugs, analgesics within the last 24 h
- Consumption of more than 100 mg of caffeine within the last 8 h
- Scar tissue or generally reduced sensitivity in the designated testing site areas
- Shoe size \< 38 (if experiment is conducted at the feet)
- History of cardiovascular disease or carotid artery disease
- Medication or Substances inferring with the autonomic nervous system or with pain sensitivity (e.g. Benzodiazepines, Nicotine)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
Switzerland · 1 center
- Balgrist University Hospital — Zurich
Identifiers
NCT: NCT06667895 · taVNS