Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain

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

Study Overview

• Status: Active, not recruiting
• Conditions: Low Back Pain; Experimental Pain
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 323060000
      • Florida State University
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Healthy subjects and individuals with chronic low back pain

Description

Healthy subjects for both MGH and FSU sites

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No intervention; 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.	Other: No intervention; No intervention involved in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
thalamocortical functional connectivity	functional connectivity between the thalamus and cortex as measured by resting state fMRI	baseline
alpha oscillations	alpha oscillations as measured by EEG and MEG	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
alpha band source	MEG and EEG data will be used to estimate the alpha band source	Baseline

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Actual): December 20, 2024
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: EEG, fMRI, thalamus, pain, experimental pain, low back pain
• Additional Relevant MeSH Terms: Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Low Back Pain
• Other Study ID Numbers: 2022p003171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No