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van CCT (UK)

van CCT (UK)

Modulation of Electrical Brain Responses by Nociceptive Stimulus Properties

- candidate number28240
- NTR NumberNTR6869
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-nov-2017
- Secondary IDsP17-19 METC Twente, Enschede
- Public TitleModulation of Electrical Brain Responses by Nociceptive Stimulus Properties
- Scientific TitleModulation of Electrical Brain Responses by Nociceptive Stimulus Properties and Stimulus Detection: an Exploratory Study
- hypothesisN.A.
- Healt Condition(s) or Problem(s) studiedElectrocutaneous stimulation, Nociception, Chronic pain
- Inclusion criteriaAge between 18 and 40 years old.
- Exclusion criteriaParticipant refusal during the study. • Language problems. • Skin problems at site of stimulation or EEG recording. • Diabetes. • Implanted stimulation device. • Pregnancy. • Usage of analgesics within 24 hours before the experiment. • Consumption of alcohol or drugs within 24 hours before the experiment. • Pain complaints at the time of the experiment. • A medical history of chronic pain.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 21-nov-2017
- planned closingdate23-apr-2018
- Target number of participants30
- InterventionsThe participants will be asked to come to the Human Physiology Lab of the BSS Group at the University of Twente for one session. First, the participant is familiarized with the stimuli by stepwise application of increasing stimuli until stimulus detection. During the experiment, the participant will receive randomized stimuli around the detection threshold according to the multiple threshold tracking paradigm. Several types of nociceptive stimuli will be applied, while the subject’s response (detected or not detected) and the stimulus related EEG epochs will be measured.
- Primary outcomeThe primary objective of this study is to describe the quality and content of electrical brain responses of pain free subjects to electrocutaneous stimuli during multiple threshold tracking, by determining the signal-to-noise ratio of averaged responses and by exploration of the use of generalized linear mixed models to explain the variability in these responses. The data will be used for computation of a linear mixed-model describing the influence of stimulus parameters on the nociceptive evoked potential.
- Secondary outcomeAnalysis to determine if and how the EEG signal is dependent on stimulus properties like the inter-pulse interval, stimulus amplitude and stimulus detection.
- TimepointsEach subject will participate one single time in the experiment. The duration of the main experiment is approximately 50 minutes.
- Trial web site
- status[default]
- Sponsor/Initiator University of Twente, Biomedical Signals and Systems Group
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryThe development of treatments for chronic pain requires a more profound understanding of the physiological and psychological aspects of chronic pain. Several types of chronic pain are linked to increased sensitivity of the central nervous system. Therefore, it is important to study the underlying mechanisms of this increased sensitivity. However, one major obstacle is the lack of an objective measure of peripheral and central sensitivity. Tracking psychophysical thresholds of nociceptive specific electrocutaneous stimuli can facilitate the investigation of the underlying mechanisms of sensitization. Recently, a subjective method was developed for tracking multiple psychophysical thresholds over time, referred to as multiple threshold tracking (MTT), which has been shown sensitive to central changes in nociception. An objective measure of nociception related activity in the central nervous system is the electroencephalographic (EEG) signal. Multiple-trial averages of this signal, referred to as evoked potentials (EPs), have been shown to reflect nociceptive sensitivity to changes in stimulus parameters such as the number of pulses or number of trials. Since MTT has been shown to be effective in measuring the effect of stimulus parameters on stimulus detection, while the EP has been shown to reflect neurophysiological activity related to stimulus processing, a combination of both techniques might provide insight into the relation between neurophysiological activity and nociceptive stimuli. Both measures are subject to a large amount of noise as well as variation between measurements, leading to a poor signal-to-noise ratio (SNR). Doll et al. have shown that a generalized linear mixed model (GLMM) can be used to account for this variation in MTT measurements, while computing an estimate of the within-subject psychophysical function that is robust to noise. A similar mixed-regression analysis of the EPs during MTT is expected to successfully account for between-subject variations, and provide objective measures of peripheral and central sensitization.
- Main changes (audit trail)
- RECORD21-nov-2017 - 15-dec-2017

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