Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain

NCT ID: NCT05763758

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-12-31

Brief Summary

This study aims to identify spatiotemporal alterations in thalamocortical circuitry functioning in both healthy subjects and patients with chronic pain, combining multimodal neuroimaging.

Detailed Description

Investigators will pursue this goal in both experimental and clinical models at two sites (Florida State U/FSU & Mass General Hospital/MGH), implementing parallel enrollment of large and diverse samples (140 healthy participants and 60 patients with chronic low back pain/cLBP). Leveraging the fully developed multimodal neuroimaging methodology-simultaneous EEG-fMRI and combined EEG-MEG-fMRI, the investigators will investigate TC dysconnectivity (fMRI) and alpha dysrhythmia (EEG/MEG) during experimental pressure pain and chronic back pain.

Conditions

Experimental Pain; Low Back Pain

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy Control

Healthy participants will undergo multimodal neuroimaging during resting state, no-pain and painful tonic pressure presentation. At FSU, EEG and fMRI will be simultaneously acquired. At MGH, sequential MRI and MEG/EEG will be acquired.

No intervention

Intervention Type: OTHER

No intervention involved in this study

Patients with chronic low back pain

Subjects with chronic low back pain (cLBP) patients will undergo multimodal neuroimaging during resting state, no-pain and painful tonic pressure presentation. The study will only be performed at MGH, sequential MRI and MEG/EEG will be acquired.

No intervention

Intervention Type: OTHER

No intervention involved in this study

Interventions

No intervention

No intervention involved in this study

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. healthy male and female adults

2. Between the ages of 18 and 60 years

3. Meeting the MRI / MEG / EEG screening criteria

4. Fluent in English; English can be a second language provided that the patients understand all questions used in the assessment measures. This will be asked and judged during the phone screen.

1. Volunteers 18-60 years of age

2. Meet the Classification Criteria of the chronic LBP (having low back pain for more than 6 months)

3. At least 4/10 clinical pain on the 0-10 LBP NRS

4. Meeting the MRI / MEG / EEG screening criteria

5. Fluent in English; English can be a second language provided that the patients understand all questions used in the assessment measures. This will be asked and judged during the phone screen.

Exclusion Criteria

1. Current or past history of major medical, neurological, or psychiatric illness based on self-report

2. History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome (for example: asthma or claustrophobia)

3. History of head trauma

4. Pregnant or lactating

5. Presence of any contraindications to MRI scanning (for example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in fMRI scanner)

6. Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1)

7. Active substance abuse disorders (based on subject self-report)

Subjects with chronic low back pain (MGH site)

1. Specific causes of back pain (eg, cancer, fractures, spinal stenosis, infections)

2. Complicated back problems (eg, prior back surgery, medicolegal issues)

3. The intent to undergo surgery during the time of involvement in the study

4. Current or past history of major medical, neurological, or psychiatric illness based on self-report

5. History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome (for example: asthma or claustrophobia)

6. History of head trauma

7. Pregnant or lactating

8. Presence of any contraindications to MRI scanning (for example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in fMRI scanner)

9. Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1)

10. Active substance abuse disorders (based on subject self-report)

11. Regular use of pain medication such as opioids, nonopioid analgesics, coanalgesics, corticosteroids, or immunomodulatory agents

12. Current use of psychotropic medication

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Florida State University

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jian Kong

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Florida State University

Tallahassee, Florida, United States

Massachusetts General Hospital

Charlestown, Massachusetts, United States

Countries

United States

Central Contacts

Jian Kong

Role: CONTACT

jkong2@mgh.harvard.edu

16179620978

Facility Contacts

Wen Li

Role: primary

wenli@psy.fsu.edu

850-645-1409

Other Identifiers

2022p003171

Identifier Type: -

Identifier Source: org_study_id