Functional Neuroimaging of Pain Using EEG and fMRI
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ClinicalTrials.gov Identifier: NCT02212691 |
Recruitment Status :
Completed
First Posted : August 8, 2014
Last Update Posted : November 1, 2019
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Condition or disease |
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Sickle Cell Disease |
Functional imaging of brain networks associated with pain processing is of vital importance to aid developing new pain-relief therapy and to better understand the mechanisms of brain function. The pain response in the brain is a complex process, which involves multiple cortical brain regions, such as primary and secondary somatosensory cortices, anterior cingulate cortex, and insular cortex . Recent advancement in neuroimaging techniques suggests the possibility to map the brain structure and networks that involve pain processing. Electroencephalography (EEG) is a noninvasive monitoring technique, which is widely used to probe neurological disorders with high temporal resolution. Few attempts have been made to use EEG to map the active brain regions in pain patients. Functional MRI (fMRI) measures the hemodynamic brain response and could image the active brain regions with high spatial resolution. Studies have shown that fMRI is a useful tool to delineate the brain regions associated with pain processing. Recent studies from simultaneous EEG and fMRI recording have suggested that the EEG response to the pain may be correlated with the fMRI response, and both EEG and fMRI could be used to image the brain pain processing regions, such as the primary somatosensory cortex and anterior cingulate cortex.
The aim of this research is to develop and evaluate a functional neuroimaging approach using EEG, fMRI and EEG-fMRI, in pain study. EEG, fMRI, or simultaneous EEG-fMRI will be collected in healthy subjects who receive external thermal stimulation inducing pain. The painful stimuli will be delivered at different intensity levels and the subject pain rating will be collected. The imaging technique combines the EEG signal with high temporal resolution and the fMRI signal with high spatial resolution to obtain a spatiotemporal imaging of the brain electrophysiological and hemodynamic activity in response to different levels of pain. Cross validation between this method and subject pain score will be used to quantitatively and qualitatively evaluate the technique. The successful completion of the current protocol will help establish an important imaging technology accessing pain level in an objective way.
Study Type : | Observational |
Actual Enrollment : | 57 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Functional Neuroimaging of Pain in Sickle Cell Disease Patients |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | December 15, 2017 |
Actual Study Completion Date : | December 15, 2017 |

Group/Cohort |
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Sickle cell disease
Patients diagnosed with sickle cell disease
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Healthy control
Healthy individuals recruited through fliers and have no history of cognitive disorders
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- Changes in EEG power [ Time Frame: up to four years ]The goal is to find biomarkers using EEG/fMRI to noninvasively quantify pain. The investigators will measure the differences in EEG power in patients with sickle cell disease comparing to healthy controls.
- Changes in fMRI activity level [ Time Frame: up to four years ]The goal is to find biomarkers using EEG/fMRI to noninvasively quantify pain. The investigators will measure the differences in fMRI BOLD activation in patients with sickle cell disease comparing to healthy controls.

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Ages Eligible for Study: | 16 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Healthy subjects with no known neurological disorders
- Sickle cell patients with no metal implants
Exclusion Criteria:
- Age over 65 in either group

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212691
United States, Minnesota | |
Biomedical Engineering Department | |
Minneapolis, Minnesota, United States, 55413 |
Principal Investigator: | Bin He, PhD | University of Minnesota |
Documents provided by University of Minnesota:
Responsible Party: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT02212691 |
Other Study ID Numbers: |
1211M24481 U01HL117664 ( U.S. NIH Grant/Contract ) |
First Posted: | August 8, 2014 Key Record Dates |
Last Update Posted: | November 1, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Sickle Cell |
Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia |
Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |