Clinical trial NCT05763758: Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain
Official title: Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Experimental Pain
Low Back Pain
Keywords: EEG, fMRI, thalamus, pain, experimental pain, low back pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Florida State University
First posted: 2023-03-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects and individuals with chronic low back pain

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.

Eligibility criteria: 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

Primary outcomes:
measure: thalamocortical functional connectivity
timeFrame: baseline
measure: alpha oscillations
timeFrame: baseline
Secondary outcomes:
measure: alpha band source
timeFrame: Baseline
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: