Pain Perception and the Autonomic Nervous System

NCT06667895 | Not Yet Recruiting DMC

• 1 other identifier: taVNS
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autonomic Nervous System Modulation; Pain Perception; Pain Sensitivity; Central Sensitization; Vagus Nerve Stimulations

Outcome Measures

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

  Before, during, and/or immediately after the intervention

Other Outcomes (4)

• Area of Secondary Hyperalgesia

  Before and 20 min after the intervention

• Changes of Pressure Pain Threshold

  Before, during, and/or immediately after the intervention

• Perceived Pain Intensity and Unpleasantness

  Before, during, and/or immediately after the intervention

Study Arms (2)

taVNS

EXPERIMENTAL

Electrodes will be attached to the outer ear. Electrical stimulation pulses with a width of 250ms will be applied at a frequency of 25Hz. Stimulation intensity will be individually adjusted to be clearly perceived but not painful.

Other: respiratory gated taVNS; Other: random burst stimulation; Other: continuous stimulation

Sham stimulation

SHAM COMPARATOR

Electrodes will be attached to the outer ear at a different position as for the taVNS. Electrical stimulation pulses with a width of 250ms will be applied at a frequency of 25Hz. Stimulation intensity will be individually adjusted to be clearly perceived but not painful.

Other: Sham stimulation

Interventions

respiratory gated taVNS OTHER

Electrical stimulation will be delivered in bursts during expiration

taVNS

random burst stimulation OTHER

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

taVNS

continuous stimulation OTHER

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

taVNS

Sham stimulation OTHER

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

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Over 18 and below 40 years of age
• Good general health
• Able to give informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Schweinhardt Petra: lead

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

Location

Study Officials

• Petra Schweinhardt, PhD, M Chiro Med

  Balgrist University Hospital, University of Zurich, Zurich, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra Schweinhardt, PhD, M Chiro Med

CONTACT

+41 443865724; petra.schweinhardt@balgrist.ch

Madeleine Hau

CONTACT

+41 443865711; madeleine.hau@balgrist.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: This study will be conducted in two phases, a pilot phase and a main experimental phase. The two phases involve different outcome measures. Both phases follow a double-blinded, randomized, within-subject design.

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: October 31, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 31, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: The PID, the study protocol and the analytical code will be available after publication for a maximum duration of 10 years
• Access Criteria: PID will be made available for research purposes only. Anonymized data of all outcome measures can be made available upon request to the sponsor-investigator.

Locations

CH (1)