Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-31 @ 2:30 AM
Study NCT ID:
NCT06667895
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-31
First Post:
2024-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Perception and the Autonomic Nervous System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 146}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-30', 'studyFirstSubmitDate': '2024-09-06', 'studyFirstSubmitQcDate': '2024-10-30', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Area of Secondary Hyperalgesia', 'timeFrame': 'Before and 20 min after the intervention', 'description': 'Von Frey filaments will be used to assess the spatial extent of experimentally induced hyperalgesia'}, {'measure': 'Changes of Pressure Pain Threshold', 'timeFrame': 'Before, during, and/or immediately after the intervention', 'description': 'Pressure will be applied over the thenar eminance of the hand until the participant reports a painful sensation'}, {'measure': 'Perceived Pain Intensity and Unpleasantness', 'timeFrame': 'Before, during, and/or immediately after the intervention', 'description': "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."}, {'measure': 'Change in Autonomic Nervous System Activity', 'timeFrame': 'Before, during, and up to 2 min after the intervention.', 'description': 'The activity of the autonomic nervous system will be measures using electrocardiogramm and galvanic skin response'}], 'primaryOutcomes': [{'measure': 'Magnitude of the Nociceptive Withdrawl Reflex', 'timeFrame': 'Before, during, and/or immediately after the intervention', 'description': 'Muscle responses of the biceps fermoris to an electrical stimulation of the sural nerve will be measured using an electromyogramm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autonomic Nervous System Modulation', 'Pain Perception', 'Pain Sensitivity', 'Central Sensitization', 'Vagus Nerve Stimulations']}, 'descriptionModule': {'briefSummary': '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.\n\nFor 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.', 'detailedDescription': '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.\n\nDuring 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.\n\nDuring 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.\n\nIn both study phases, the activity of the autonomic nervous system will be assessed throughout the experiment, and questionnaires will be completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Over 18 and below 40 years of age\n2. Good general health\n3. Able to give informed consent\n\nExclusion Criteria:\n\n1. 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\n2. Inability to follow study instructions, e.g. due to language problems\n3. Pregnancy (female participants will be asked if pregnancy could be possible)\n4. 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)\n5. Consumption of alcohol, drugs, analgesics within the last 24 h\n6. Consumption of more than 100 mg of caffeine within the last 8 h\n7. Scar tissue or generally reduced sensitivity in the designated testing site areas\n8. Shoe size \\< 38 (if experiment is conducted at the feet)\n9. History of cardiovascular disease or carotid artery disease\n10. Medication or Substances inferring with the autonomic nervous system or with pain sensitivity (e.g. Benzodiazepines, Nicotine)'}, 'identificationModule': {'nctId': 'NCT06667895', 'briefTitle': 'Pain Perception and the Autonomic Nervous System', 'organization': {'class': 'OTHER', 'fullName': 'Balgrist University Hospital'}, 'officialTitle': 'Influences of the Autonomic Nervous System on Experimental Pain Sensitization', 'orgStudyIdInfo': {'id': 'taVNS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'taVNS', 'description': '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.', 'interventionNames': ['Other: respiratory gated taVNS', 'Other: random burst stimulation', 'Other: continuous stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham stimulation', 'description': '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.', 'interventionNames': ['Other: Sham stimulation']}], 'interventions': [{'name': 'respiratory gated taVNS', 'type': 'OTHER', 'description': 'Electrical stimulation will be delivered in bursts during expiration', 'armGroupLabels': ['taVNS']}, {'name': 'random burst stimulation', 'type': 'OTHER', 'description': 'Electrical stimulation will be delivered in bursts at random timepoints during the breathing cycle', 'armGroupLabels': ['taVNS']}, {'name': 'continuous stimulation', 'type': 'OTHER', 'description': 'Electrical stimulation will be delivered continuously for 30sec followed by a 30sec break.', 'armGroupLabels': ['taVNS']}, {'name': 'Sham stimulation', 'type': 'OTHER', 'description': 'Electrical stimulation will be identical to the taVNS, but the electrodes will be placed at a different position on the ear', 'armGroupLabels': ['Sham stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'contacts': [{'name': 'Madeleine Hau', 'role': 'CONTACT', 'email': 'madeleine.hau@balgrist.ch', 'phone': '+41 44 386 57 11'}], 'facility': 'Balgrist University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Petra Schweinhardt, PhD, M Chiro Med', 'role': 'CONTACT', 'email': 'petra.schweinhardt@balgrist.ch', 'phone': '+41 443865724'}, {'name': 'Madeleine Hau', 'role': 'CONTACT', 'email': 'madeleine.hau@balgrist.ch', 'phone': '+41 443865711'}], 'overallOfficials': [{'name': 'Petra Schweinhardt, PhD, M Chiro Med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Balgrist University Hospital, University of Zurich, Zurich, Switzerland'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ANALYTIC_CODE'], 'timeFrame': 'The PID, the study protocol and the analytical code will be available after publication for a maximum duration of 10 years', 'ipdSharing': 'YES', 'description': 'Data of participants who gave informed consent for further use of their anonymized data will be made available upon request.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schweinhardt Petra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Schweinhardt Petra', 'investigatorAffiliation': 'Balgrist University Hospital'}}}}