Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain

NCT05763758 | Unknown

• 1 other identifier: 2022p003171
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Experimental Pain; Low Back Pain

Keywords

EEG, fMRI, thalamus, pain, experimental pain, low back pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• alpha band source

  Baseline

Study Arms (2)

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

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

Interventions

No intervention OTHER

No intervention involved in this study

Healthy Control; Patients with chronic low back pain

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy subjects and individuals with chronic low back pain

You may qualify if:

• healthy male and female adults
• Between the ages of 18 and 60 years
• Meeting the MRI / MEG / EEG screening criteria
• 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.

You may not qualify if:

• Current or past history of major medical, neurological, or psychiatric illness based on self-report
• 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)
• History of head trauma
• Pregnant or lactating
• Presence of any contraindications to MRI scanning (for example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in fMRI scanner)
• 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)
• Active substance abuse disorders (based on subject self-report)
• Subjects with chronic low back pain (MGH site)
• Volunteers 18-60 years of age
• Meet the Classification Criteria of the chronic LBP (having low back pain for more than 6 months)
• At least 4/10 clinical pain on the 0-10 LBP NRS
• Meeting the MRI / MEG / EEG screening criteria
• 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.
• Specific causes of back pain (eg, cancer, fractures, spinal stenosis, infections)
• Complicated back problems (eg, prior back surgery, medicolegal issues)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Florida State University: collaborator

Study Sites (2)

Florida State University

Tallahassee, Florida, 323060000, United States

Location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Low Back Pain; Pain

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jian Kong

CONTACT

16179620978; jkong2@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: May 1, 2023
• Primary Completion: October 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)