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Completed

NCT Number: NCT02212691

Functional Neuroimaging of Pain Using EEG and fMRI

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

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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Biomedical Engineering Department

Minneapolis, Minnesota, 55413, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age over 65 in either group

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Functional Neuroimaging of Pain in Sickle Cell Disease Patients

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Aug 8, 2014
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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