Functional Neuroimaging of Pain Using EEG and fMRI

NCT ID: NCT02212691

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 57 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2017-12-15

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.

Conditions

Sickle Cell Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Sickle cell disease

Patients diagnosed with sickle cell disease

No interventions assigned to this group

Healthy control

Healthy individuals recruited through fliers and have no history of cognitive disorders

No interventions assigned to this group

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bin He, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Biomedical Engineering Department

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 29343982 (View on PubMed)

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: 10.1016/j.nicl.2018.11.009. Epub 2018 Nov 14.

Reference Type: RESULT

PMID: 30477765 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U01HL117664

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1211M24481

Identifier Type: -

Identifier Source: org_study_id