Experimental PainNCT05763758
Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain
An observational study of Experimental Pain and Low Back Pain, run by Massachusetts General Hospital at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Experimental Pain, Low Back Pain
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Nov 2023to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy subjects and individuals with chronic low back pain
Who may be able to join
- 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.
- Volunteers 18-60 years of age
- Meet the Classification Criteria of the chronic LBP (having low back pain for more than 6 months)
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- 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.
Who cannot join
- 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)
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- Active substance abuse disorders (based on subject self-report)
- Subjects with chronic low back pain (MGH site)
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
Florida State University
Tallahassee, Florida, 323060000
About this study
This study aims to identify spatiotemporal alterations in thalamocortical circuitry functioning in both healthy subjects and patients with chronic pain, combining multimodal neuroimaging.
Read the 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.
- Conditions
- Experimental Pain, Low Back Pain
- Being tested
- No intervention
- Keywords
- EEG, fMRI, thalamus, pain, experimental pain, low back pain
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention involved in this study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
thalamocortical functional connectivity
functional connectivity between the thalamus and cortex as measured by resting state fMRI
Measured: baseline
alpha oscillations
alpha oscillations as measured by EEG and MEG
Measured: baseline
Secondary outcomes (1)
alpha band source
MEG and EEG data will be used to estimate the alpha band source
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start21 Nov 2023
- Primary completion20 Dec 2024
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Experimental PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Florida State University
- Responsible party
- Principal investigator, Jian Kong, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763758
- Sponsor's protocol ID
- 2022p003171
- Status last verified
- Jul 2026
- First submitted
- 28 Feb 2023
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain
- ClinicalTrials.gov ID
- NCT05763758
- Acronym / sponsor ID
- 2022p003171
- Conditions
- Experimental Pain, Low Back Pain
- Keywords
- EEG, fMRI, thalamus, pain, experimental pain, low back pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Florida State University
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | Other: No interventionHealthy 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. |
| Patients with chronic low back pain | – | Other: No interventionSubjects 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy subjects and individuals with chronic low back pain
Key inclusion criteria (9 listed)
- 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.
- Volunteers 18-60 years of age
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention involved in this study | Other | Healthy Control, Patients with chronic low back pain |
Primary outcome
thalamocortical functional connectivity
Time frame: baseline
functional connectivity between the thalamus and cortex as measured by resting state fMRI
alpha oscillations
Time frame: baseline
alpha oscillations as measured by EEG and MEG
1 secondary outcome
alpha band source
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Experimental Pain and Low Back Pain, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thalamocortical functional connectivity (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.