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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date August 1, 2014
First Posted Date August 8, 2014
Last Update Posted Date November 1, 2019
Study Start Date January 2012
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2019)
  • 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.
Original Primary Outcome Measures
 (submitted: August 7, 2014)
Changes in EEG power and 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 EEG power in patients with sickle cell disease comparing to healthy controls, changes of fMRI activity level comparing to healthy controls.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Functional Neuroimaging of Pain Using EEG and fMRI
Official Title Functional Neuroimaging of Pain in Sickle Cell Disease Patients
Brief Summary The purpose of this research is to use non-invasive imaging technologies to study how the human brain processes pain. The investigators will use contact heat to induce pain and record data scalp EEG and functional magnetic resonance imaging (fMRI). What the investigators learn from this study will help us gain insights in pain management with broad socioeconomic impacts
Detailed Description

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
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy subjects Sickle cell patients
Condition Sickle Cell Disease
Intervention Not Provided
Study Groups/Cohorts
  • Sickle cell disease
    Patients diagnosed with sickle cell disease
  • Healthy control
    Healthy individuals recruited through fliers and have no history of cognitive disorders
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 3, 2019)
57
Original Estimated Enrollment
 (submitted: August 7, 2014)
25
Actual Study Completion Date December 15, 2017
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Healthy subjects with no known neurological disorders
  • Sickle cell patients with no metal implants

Exclusion Criteria:

  • Age over 65 in either group
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02212691
Other Study ID Numbers 1211M24481
U01HL117664 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Minnesota
Study Sponsor University of Minnesota
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Bin He, PhD University of Minnesota
PRS Account University of Minnesota
Verification Date October 2019