Pain Perception and the Autonomic Nervous System

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorSchweinhardt Petra

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Over 18 and below 40 years of age

Good general health

Able to give informed consent

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • respiratory gated taVNS

    Other intervention

    Electrical stimulation will be delivered in bursts during expiration

  • random burst stimulation

    Other intervention

    Electrical stimulation will be delivered in bursts at random timepoints during the breathing cycle

  • continuous stimulation

    Other intervention

    Electrical stimulation will be delivered continuously for 30sec followed by a 30sec break.

  • Sham stimulation

    Other intervention

    Electrical stimulation will be identical to the taVNS, but the electrodes will be placed at a different position on the ear

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: taVNSExperimental treatment 3 interventions
Group B: Sham stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Magnitude of the Nociceptive Withdrawl Reflex

Muscle responses of the biceps fermoris to an electrical stimulation of the sural nerve will be measured using an electromyogramm

Time frame
Before, during, and/or immediately after the intervention

Secondary outcomes

Other outcomes

1

Area of Secondary Hyperalgesia

Von Frey filaments will be used to assess the spatial extent of experimentally induced hyperalgesia

Time frame
Before and 20 min after the intervention
2

Changes of Pressure Pain Threshold

Pressure will be applied over the thenar eminance of the hand until the participant reports a painful sensation

Time frame
Before, during, and/or immediately after the intervention
3

Perceived Pain Intensity and Unpleasantness

Perceived intensity and unpleasantness of heat stimuli will be assessed using rating scales. The intensity rating scale ranges from 0, indicating no perception, to 100, indicating the pain threshold, and up to 200, indicating the most tolerable pain. The unpleasantness rating scale ranges from -100 for 'extremely unpleasant,' through 0 for 'neutral,' to 100 for 'extremely pleasant.

Time frame
Before, during, and/or immediately after the intervention
4

Change in Autonomic Nervous System Activity

The activity of the autonomic nervous system will be measures using electrocardiogramm and galvanic skin response

Time frame
Before, during, and up to 2 min after the intervention.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Schweinhardt Petra

Lead sponsor

Balgrist University Hospital

Sponsor institution

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