Autonomic Nervous System ModulationNCT06667895
Pain Perception and the Autonomic Nervous System
A study testing respiratory gated taVNS, random burst stimulation and continuous stimulation in people with Autonomic Nervous System Modulation and Pain Perception, run by Schweinhardt Petra at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System Modulation, Pain Perception, Pain Sensitivity
- What is being tested?
- respiratory gated taVNS, random burst stimulation and continuous stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Nov 2024to Aug 2026
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Over 18 and below 40 years of age
- Good general health
- Able to give informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
Madeleine Hau, +41 44 386 57 11, madeleine.hau@balgrist.ch
About this study
Official title: Influences of the Autonomic Nervous System on Experimental Pain Sensitization
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.
Read the 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.
- Conditions
- Autonomic Nervous System Modulation, Pain Perception, Pain Sensitivity, Central Sensitization, Vagus Nerve Stimulations
- Being tested
- respiratory gated taVNS, random burst stimulation, continuous stimulation, Sham stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory gated taVNSOther
Electrical stimulation will be delivered in bursts during expiration
random burst stimulationOther
Electrical stimulation will be delivered in bursts at random timepoints during the breathing cycle
continuous stimulationOther
Electrical stimulation will be delivered continuously for 30sec followed by a 30sec break.
Sham stimulationOther
Electrical stimulation will be identical to the taVNS, but the electrodes will be placed at a different position on the ear
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before, during, and/or immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start4 Nov 2024 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous System ModulationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schweinhardt Petra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Schweinhardt Petra, Balgrist University Hospital
- Investigators
- Petra Schweinhardt, PhD, M Chiro Med, Principal investigator, Balgrist University Hospital, University of Zurich, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667895
- Sponsor's protocol ID
- taVNS
- Status last verified
- Aug 2024
- First submitted
- 6 Sep 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data of participants who gave informed consent for further use of their anonymized data will be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influences of the Autonomic Nervous System on Experimental Pain Sensitization
- ClinicalTrials.gov ID
- NCT06667895
- Acronym / sponsor ID
- taVNS
- Conditions
- Autonomic Nervous System Modulation, Pain Perception, Pain Sensitivity, Central Sensitization, Vagus Nerve Stimulations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Schweinhardt PetraUniversity, hospital or other
- Study start
- 4 Nov 2024 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 31 Oct 2024 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| taVNS | Experimental | Other: respiratory gated taVNS, Other: random burst stimulation, Other: continuous stimulationElectrodes 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. |
| Sham stimulation | Sham comparator | Other: Sham stimulationElectrodes 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Over 18 and below 40 years of age
- Good general health
- Able to give informed consent
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| respiratory gated taVNSElectrical stimulation will be delivered in bursts during expiration | Other | taVNS |
| random burst stimulationElectrical stimulation will be delivered in bursts at random timepoints during the breathing cycle | Other | taVNS |
| continuous stimulationElectrical stimulation will be delivered continuously for 30sec followed by a 30sec break. | Other | taVNS |
| Sham stimulationElectrical stimulation will be identical to the taVNS, but the electrodes will be placed at a different position on the ear | Other | Sham stimulation |
Primary outcome
Magnitude of the Nociceptive Withdrawl Reflex
Time frame: Before, during, and/or immediately after the intervention
Muscle responses of the biceps fermoris to an electrical stimulation of the sural nerve will be measured using an electromyogramm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: Yes. Data of participants who gave informed consent for further use of their anonymized data will be made available upon request.
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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.
Petra Schweinhardt, PhD, M Chiro Med principal investigator
Balgrist University Hospital, University of Zurich, Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing respiratory gated taVNS, random burst stimulation and continuous stimulation in people with Autonomic Nervous System Modulation and Pain Perception, run by Schweinhardt Petra at 1 site in Switzerland.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 31 Oct 2024. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petra Schweinhardt, PhD, M Chiro Med (+41 443865724, petra.schweinhardt@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of the Nociceptive Withdrawl Reflex (time frame: Before, during, and/or immediately after the intervention). 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 31 Oct 2024.