Functional Neuroimaging of Pain Using EEG and fMRI

Sickle Cell Disease Clinical Trial

Official title:

Functional Neuroimaging of Pain in Sickle Cell Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212691
• Other study ID #: 1211M24481
• Secondary ID: U01HL117664
• Status: Completed
• Start date: January 2012
• Est. completion date: December 15, 2017

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy subjects with no known neurological disorders

• Sickle cell patients with no metal implants

Exclusion Criteria:

• Age over 65 in either group

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Locations

Country	Name	City	State
United States	Biomedical Engineering Department	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Case M, Shirinpour S, Vijayakumar V, Zhang H, Datta Y, Nelson S, Pergami P, Darbari DS, Gupta K, He B. Graph theory analysis reveals how sickle cell disease impacts neural networks of patients with more severe disease. Neuroimage Clin. 2019;21:101599. doi — View Citation

Case M, Shirinpour S, Zhang H, Datta YH, Nelson SC, Sadak KT, Gupta K, He B. Increased theta band EEG power in sickle cell disease patients. J Pain Res. 2017 Dec 27;11:67-76. doi: 10.2147/JPR.S145581. eCollection 2018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in EEG power	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.	up to four years
Primary	Changes in fMRI activity level	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.	up to four years