Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
146 participants
INTERVENTIONAL
2024-11-04
2026-08-31
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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taVNS
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.
respiratory gated taVNS
Electrical stimulation will be delivered in bursts during expiration
random burst stimulation
Electrical stimulation will be delivered in bursts at random timepoints during the breathing cycle
continuous stimulation
Electrical stimulation will be delivered continuously for 30sec followed by a 30sec break.
Sham stimulation
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.
Sham stimulation
Electrical stimulation will be identical to the taVNS, but the electrodes will be placed at a different position on the ear
Interventions
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respiratory gated taVNS
Electrical stimulation will be delivered in bursts during expiration
random burst stimulation
Electrical stimulation will be delivered in bursts at random timepoints during the breathing cycle
continuous stimulation
Electrical stimulation will be delivered continuously for 30sec followed by a 30sec break.
Sham stimulation
Electrical stimulation will be identical to the taVNS, but the electrodes will be placed at a different position on the ear
Eligibility Criteria
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Inclusion Criteria
2. Good general health
3. Able to give informed consent
Exclusion Criteria
2. Inability to follow study instructions, e.g. due to language problems
3. Pregnancy (female participants will be asked if pregnancy could be possible)
4. 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)
5. Consumption of alcohol, drugs, analgesics within the last 24 h
6. Consumption of more than 100 mg of caffeine within the last 8 h
7. Scar tissue or generally reduced sensitivity in the designated testing site areas
8. Shoe size \< 38 (if experiment is conducted at the feet)
9. History of cardiovascular disease or carotid artery disease
10. Medication or Substances inferring with the autonomic nervous system or with pain sensitivity (e.g. Benzodiazepines, Nicotine)
18 Years
40 Years
ALL
Yes
Sponsors
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Schweinhardt Petra
OTHER
Responsible Party
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Schweinhardt Petra
Prof. Dr. med.
Principal Investigators
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Petra Schweinhardt, PhD, M Chiro Med
Role: PRINCIPAL_INVESTIGATOR
Balgrist University Hospital, University of Zurich, Zurich, Switzerland
Locations
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Balgrist University Hospital
Zurich, Canton of Zurich, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Madeleine Hau
Role: primary
Other Identifiers
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taVNS
Identifier Type: -
Identifier Source: org_study_id