Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain

Not yet recruiting

• Conditions: Experimental Pain; Low Back Pain
• Interventions: Other: No intervention

• Registration Number: NCT05763758
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Status Verified: 2023-03
• Study First Posted: 2023-03-10
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23
• Study Start: 2023-05-01
• Primary Completion: 2024-10-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

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)

Inclusion Criteria:

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. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with chronic low back pain	No intervention	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.
Healthy Control	No intervention	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.

Primary Outcome Measures

Name	Time	Method
thalamocortical functional connectivity	baseline	functional connectivity between the thalamus and cortex as measured by resting state fMRI
alpha oscillations	baseline	alpha oscillations as measured by EEG and MEG

Secondary Outcome Measures

Name	Time	Method
alpha band source	Baseline	MEG and EEG data will be used to estimate the alpha band source

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Charlestown, Massachusetts, United States

Florida State University; 🇺🇸 Tallahassee, Florida, United States