Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-24 @ 1:43 PM
Study NCT ID:
NCT06667895
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-31
First Post:
2024-09-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain Perception and the Autonomic Nervous System
Sponsor:
Schweinhardt Petra
Organization:
Study Overview
Official Title:
Influences of the Autonomic Nervous System on Experimental Pain Sensitization
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: