Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain

Low Back Pain Clinical Trial

Official title:

Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05763758
• Other study ID #: 2022p003171
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Massachusetts General Hospital
• Contact: Jian Kong
• Phone: 16179620978
• Email: jkong2[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Experimental Pain
• Low Back Pain

Intervention

Other:
• No intervention
No intervention involved in this study

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts
United States	Florida State University	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thalamocortical functional connectivity	functional connectivity between the thalamus and cortex as measured by resting state fMRI	baseline
Primary	alpha oscillations	alpha oscillations as measured by EEG and MEG	baseline
Secondary	alpha band source	MEG and EEG data will be used to estimate the alpha band source	Baseline