- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04675047
Multimodal Brain Decoding of Pain Sensitivity
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:
- To establish a Taiwan database of pain sensitivity. Meanwhile, to clarify the interactions between the innate and environmental factors of the individual and the brain network, and to identify brain signatures related to pain sensitivity. (sub- projects A, B, C)
- To confirm the brain signatures for predicting the pain sensitivity using machine learning. In addition, to develop wearable devices such as EEG cap for large sample screening by combining the brain-computer interface through the industry-university cooperation (sub-projects B, C, D)
- To explore the plasticity of brain signatures related to pain sensitivity by sensory modulation such as music, painting appreciation or transcutaneous electrical nerve stimulation, and to explore the application potential for pain modulation (sub-projects B, C, D, E)
- Based on the cooperation model of this international research team, we will cultivate young researchers, and promote academic interactions among different team members, and improve the international visibility and competitiveness of Taiwan (sub-projects A, B, C, D, E)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Taipei city, Taiwan, 112
- National Yang-Ming University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- aged 20-55
- understand the study and provide informed consent
Exclusion Criteria:
- Any acute or chronic condition that could potentially affect pain perception, including diabetes, hypertension, peripheral and central nervous disorders
- Presence of any pain disorder or suffering from any acute pain within 2 weeks
- History of any neurological disease, except primary headache with headache frequency less than 1 days per month
- Psychiatric disorders including major depressive disorder, post-traumatic stress disorder, personality disorder, bipolar disorder, and schizophrenia
- History of substance abuse, including alcohol, analgesic, and illicit drugs.
- Any condition that would make participants contra-indicated to magnetic resonance imaging (MRI) scans transcutaneous electrical nerve stimulation (TENS), or electroencephalography (EEG).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
healthy control
|
observational study - no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sensory thresholds
Time Frame: 30 minutes
|
Using quantitative sensory testing (QST) to evaluate the sensory threshold
|
30 minutes
|
EEG change (1)
Time Frame: 10 minutes
|
Linear analysis of EEG with pain sensitivity
|
10 minutes
|
EEG change (2)
Time Frame: 10 minutes
|
Nonlinear analysis of EEG with pain sensitivity
|
10 minutes
|
MRI
Time Frame: 90 minutes
|
Analysis of MRI correlatin with pain sensitivity
|
90 minutes
|
fMRI
Time Frame: 90 minutes
|
Analysis of fMRI correlatin with pain sensitivity
|
90 minutes
|
Humoral relationship (1)
Time Frame: 5 minutes
|
Test the related hormones to evaluate the relationship with sensitivity
|
5 minutes
|
Humoral relationship (2)
Time Frame: 5 minutes
|
Test the related cytokines to evaluate the relationship with sensitivity
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
innate and environmental factors associated with pain sensitivity
Time Frame: 5 minutes
|
explory potential factors that may influence the pain sensitivity
|
5 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YM108044F
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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