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NCT Number: NCT05763758

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Florida State University, Tallahassee, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Healthy subjects for both MGH and FSU sites

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Inclusion criteria

  • 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.

Exclusion criteria

  • Specific causes of back pain (eg, cancer, fractures, spinal stenosis, infections)
  • Complicated back problems (eg, prior back surgery, medicolegal issues)
  • The intent to undergo surgery during the time of involvement in the study
  • 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)
  • Regular use of pain medication such as opioids, nonopioid analgesics, coanalgesics, corticosteroids, or immunomodulatory agents
  • Current use of psychotropic medication

Treatment and study plan

No intervention

Other

No intervention involved in this study

Primary outcomes

  1. thalamocortical functional connectivity

    Time frame: baseline

    functional connectivity between the thalamus and cortex as measured by resting state fMRI

  2. alpha oscillations

    Time frame: baseline

    alpha oscillations as measured by EEG and MEG

Secondary outcomes

  1. alpha band source

    Time frame: Baseline

    MEG and EEG data will be used to estimate the alpha band source

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Florida State University

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Mar 10, 2023
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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