Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06183593
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2023-12-14
Brief Title:
Accuracy in the Evaluation of Brain Response to Mechanical and Radiofrequency Stimuli in Humans
Sponsor:
National Council of Scientific and Technical Research Argentina
Organization:
National Council of Scientific and Technical Research Argentina
Study Overview
Official Title:
Accuracy in the Evaluation of Brain Response to Mechanical and Radiofrequency Stimuli in Humans
Status:
COMPLETED
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:
Under normal conditions pain arises as a consequence of the activation of nociceptive afferents small fibers by an external stimulus with sufficient intensity to potentially cause tissue damage This peripheral activation is processed as perception of pain by the central nervous system In order to reliably evaluate the state of the nociceptive system in both clinical and experimental settings standardized tests are essential Quantitative sensory testing QST is a set of tests used to measure the intensity of a stimulus that produces a specific sensory perception in a subject For example if we gradually apply pressure the point where the sensation changes from pressure to pain is called the pressure pain threshold This type of test can be performed with different types of stimuli including hot and cold stimuli or mechanical stimuli Although these tests have been shown as reliable in healthy volunteers and pain patients they are subjective in their nature since they are based on a conscious evaluation of tested subjects Likewise these measures show substantial variability due to differences in the application of the tests by individual examinators In short even though the method is quantitative its methodological characteristics make it subjective and dependent on both the operator and the subject under study Moreover contrasting results have been recently found regarding the measurement variability when repeating the QST at intervals of days Thus it is essential to investigate and develop new QST alternatives to obtain objective markers that may potentially contribute to the understanding of the mechanisms behind chronic pain conditions
Detailed Description:
Under normal conditions pain arises as a consequence of the activation of nociceptive afferents small fibers by an external stimulus with sufficient intensity to potentially cause tissue damage This peripheral activation is processed as perception of pain by the central nervous system In order to reliably evaluate the state of the nociceptive system in both clinical and experimental settings standardized tests are essential Quantitative sensory testing QST is a set of tests used to measure the intensity of a stimulus that produces a specific sensory perception in a subject For example if we gradually apply pressure the point where the sensation changes from pressure to pain is called the pressure pain threshold This type of test can be performed with different types of stimuli including hot and cold stimuli or mechanical stimuli Although these tests have been shown as reliable in healthy volunteers and pain patients they are subjective in their nature since they are based on a conscious evaluation of tested subjects Likewise these measures show substantial variability due to differences in the application of the tests by individual examinators In short even though the method is quantitative its methodological characteristics make it subjective and dependent on both the operator and the subject under study Moreover contrasting results have been recently found regarding the measurement variability when repeating the QST at intervals of days Thus it is essential to investigate and develop new QST alternatives to obtain objective markers that may potentially contribute to the understanding of the mechanisms behind chronic pain conditions
In this regard evoked potentials EP measured by electroencephalography EEG are the most commonly used objective alternative for the functional evaluation of small fibers and the spinothalamic tract Nociceptive EPs can be induced with various stimulation modalities including lasers LEP contact heat CHEP and cold CCEP intradermal electrical stimulation IEEP and mechanical needling PEP and each modality has its own advantages and disadvantages Recently a novel type of EP has been proposed that is evoked by electrical stimulation in the range of 200 kHz to 33 MHz that is in the radio frequency RF spectrum At such high frequencies the nerves and muscles can no longer be electrically excited and the physiological effects are generated exclusively due to the heating of the tissue In strictly physiological terms RF electrical stimuli are similar to those generated by contact heat Importantly non-ablative RF technology is safe relatively inexpensive and in widespread use in clinics Beasley Weiss 2014 Lolis Goldberg 2012- Therefore the use of RF stimulation could significantly increase the accessibility of EPs as a reference electrophysiological tool for the evaluation of the state of the nociceptive system
Another attractive alternative to subjective evaluation is the EP elicited by sharp mechanical stimuli pinprick A device that applies this type of stimulus has recently been developed It uses a stimulator with a tip similar to that of a blunt needle which allows obtaining brain responses synchronized with the stimulus and evaluating the state of the spino-thalamic-cortical mechanical sensory conduction pathways At the Faculty of Engineering of the National University of Entre Ríos FI-UNER a prototype was developed that allows it to be carried out in an automated manner which allows to reduce the uncertainty derived from human subjectivity
In the proposed protocol the precision of the brain response to RF and mechanical sharp stimuli will be evaluated in two experimental settings We plan to assess the effect of stimulation intensity on signal parameters such as EP latency and amplitude Furthermore the relationship of these parameters with psychophysical results questionnaires and heat thresholds will be explored to investigate the relationship between these variables
In this regard evoked potentials EP measured by electroencephalography EEG are the most commonly used objective alternative for the functional evaluation of small fibers and the spinothalamic tract Nociceptive EPs can be induced with various stimulation modalities including lasers LEP contact heat CHEP and cold CCEP intradermal electrical stimulation IEEP and mechanical needling PEP and each modality has its own advantages and disadvantages Recently a novel type of EP has been proposed that is evoked by electrical stimulation in the range of 200 kHz to 33 MHz that is in the radio frequency RF spectrum At such high frequencies the nerves and muscles can no longer be electrically excited and the physiological effects are generated exclusively due to the heating of the tissue In strictly physiological terms RF electrical stimuli are similar to those generated by contact heat Importantly non-ablative RF technology is safe relatively inexpensive and in widespread use in clinics Beasley Weiss 2014 Lolis Goldberg 2012- Therefore the use of RF stimulation could significantly increase the accessibility of EPs as a reference electrophysiological tool for the evaluation of the state of the nociceptive system
Another attractive alternative to subjective evaluation is the EP elicited by sharp mechanical stimuli pinprick A device that applies this type of stimulus has recently been developed It uses a stimulator with a tip similar to that of a blunt needle which allows obtaining brain responses synchronized with the stimulus and evaluating the state of the spino-thalamic-cortical mechanical sensory conduction pathways At the Faculty of Engineering of the National University of Entre Ríos FI-UNER a prototype was developed that allows it to be carried out in an automated manner which allows to reduce the uncertainty derived from human subjectivity
In the proposed protocol the precision of the brain response to RF and mechanical sharp stimuli will be evaluated in two experimental settings We plan to assess the effect of stimulation intensity on signal parameters such as EP latency and amplitude Furthermore the relationship of these parameters with psychophysical results questionnaires and heat thresholds will be explored to investigate the relationship between these variables
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None