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Sponsor study identifier
observational
100
1 country
1
Study Start
September 10, 2019
Actual (reported)Primary Completion
November 20, 2020
Actual (reported)Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Pain is the leading cause of disability worldwide. However, the pain sensitivity of individuals varies to a large extent, which often results in the mismatch between clinical diagnosis or treatment and individual's actual needs. There are still no established objective indicators for comparisons between individuals. This integrated pilot project is the first large-scale, multi-modal brain decoding study for pain sensitivity. We will explore the brain network signature of pain sensitivity by analyzing electroencephalogram (EEG) signals and magnetic resonance imaging (MRI.) Meanwhile, we will integrate the innate, environmental, and humanity factors with aforementioned brain network signatures to establish multi- modal objective model of pain sensitivity using machine learning. This research team is composed of more than 30 physicians, scientists, and IT experts, along with international collaborators with expertise in the fields of neuroscience, medical imaging, and human philosophy. The five elite groups constitute this international research team and establish five multi-disciplinary sub-projects: Sub-project A: Pain sensitivity and associated innate and environmental factors Sub-project B: Electrophysiological brain signatures of pain sensitivity Sub-project C: MRI brain signatures of pain sensitivity Sub-project D: Innovative brain computer interface (BCI) technology in pain sensitivity measurement and prediction Sub-project E: Pain and Art: neuro-mental mechanisms and potential applications There are three key features of this integrated project: scientific novelty, technology and humanity. In terms of scientific novelty, in addition to machine learning and big data applications, we will focus on the deep brain structure such as brainstem, in which the image acquisition has been difficult in the past. We will develop an MRI sequence and EEG protocol optimized for brainstem. In terms of technology, we will develop a wearable EEG cap implanted with algorithm chip for clinical measurement to decode the pain sensitivity real time. In terms of humanity, we will combine music and painting appreciation to explore their impact on brain signatures related to pain sensitivity. Furthermore, we will develop potential applications of art intervention in pain modulation. We expect this pilot project to achieve the four following goals:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 10, 2019
Actual (reported)November 20, 2020
Actual (reported)December 9, 2020
Actual (reported)December 19, 2020
Actual (reported)December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
sensory thresholds
Using quantitative sensory testing (QST) to evaluate the sensory threshold
30 minutes
EEG change (1)
Linear analysis of EEG with pain sensitivity
10 minutes
EEG change (2)
Nonlinear analysis of EEG with pain sensitivity
10 minutes
MRI
Analysis of MRI correlatin with pain sensitivity
90 minutes
fMRI
Analysis of fMRI correlatin with pain sensitivity
90 minutes
Humoral relationship (1)
Test the related hormones to evaluate the relationship with sensitivity
5 minutes
Humoral relationship (2)
Test the related cytokines to evaluate the relationship with sensitivity
5 minutes
innate and environmental factors associated with pain sensitivity
5 minutes
healthy control
observational study - no intervention
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Healthy control
National Yang-Ming University
Taipei, 112, Taiwan
Pan LH, Chen SP, Ling YH, Wang YF, Lai KL, Liu HY, Chen WT, Huang WJ, Coppola G, Treede RD, Wang SJ. Salivary Testosterone Levels and Pain Perception Exhibit Sex-Specific Association in Healthy Adults But Not in Patients With Migraine. J Pain. 2024 Sep;25(9):104575. doi: 10.1016/j.jpain.2024.104575. Epub 2024 May 22.
First Submitted
December 9, 2020
First Posted
December 19, 2020
Study Start
September 10, 2019
Actual (reported)Primary Completion
November 20, 2020
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 13, 2022
Record last verified: 2022-09
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Source: ClinicalTrials.gov.
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