FibromyalgiaNCT07023523
Self-regulation of Real-time fMRI Brain Activity in Chronic Pain
A study testing Cognitive Behavioral Therapy and Disease Education in people with Fibromyalgia, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study aims to explore the usefulness of self-regulation of brain activity in patients with fibromyalgia. Patients will use real-time functional magnetic resonance imaging (fMRI) neurofeedback to observe and regulate their own brain activity while applying mental strategies to reduce fibromyalgia pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Cognitive Behavioral Therapy and Disease Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2025to Feb 2027
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65
- Meet the Wolfe et al 2011 research criteria for fibromyalgia for at least one year
- On stable doses of medication prior to entering the study and agree not to change medications or dosages (or CAM treatments) during the trial
- Baseline pain intensity of at least 4/10 on average and pain report for at least 50% of days
- Able to provide written consent and fluent in English
Who cannot join
- Comorbid acute pain condition
- Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
- Stimulant medications for the fatigue associated with sleep apnea or shift work (e.g., modafinil),
- Pregnant or nursing
- Any psychiatric disorder involving a history of psychosis (e. g schizophrenia, severe personality disorders)
- History of anxiety disorders or significant anxiety symptoms interfering with fMRI procedures (e.g., panic)
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- Contraindication to MRI (e.g., implanted ferrous metal)
- History of significant head injury (e.g., with substantial loss of consciousness)
- Psychiatric hospitalization in the past 6 months
- Other contraindications to MRI
- Participating in other therapeutic trials
- Active suicidal ideation
- Documented peripheral neuropathy of known cause (e.g diabetic neuropathy, chemotherapy-induced neuropathy, guillain-barre)
- Routine or daily use of narcotics or substances of abuse
- Autoimmune or inflammatory disease (RA, SLE, IBD) that causes pain
- Lower Limb Vascular Surgery or Current Lower Limb Vascular Dysfunction
- Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator that would prevent satisfactory completion of the study protocol. This includes unreliable, or inconsistent pain scores as deemed by the principal investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Athinoula A. Martinos Center for Biomedical Imaging
Boston, Massachusetts, 02129
Soobin Choi, 617-952-6742, schoi38@mgb.org
About this study
Official title: Self-regulation of Real-time fMRI Brain Activity in Chronic Pain: A Potential Neurobiological Mechanism of Cognitive Behavioral Therapy
This study aims to explore the usefulness of self-regulation of brain activity in patients with fibromyalgia. Patients will use real-time functional magnetic resonance imaging (fMRI) neurofeedback to observe and regulate their own brain activity while applying mental strategies to reduce fibromyalgia pain. The study consists of 2 magnetic resonance imaging (MRI) visits that involve brain neuroimaging for fMRI neurofeedback tasks, as well as 8 weekly intervention sessions with a pain psychologist. Patients will be randomized to either Cognitive Behavioral Therapy (CBT) or Fibromyalgia Education groups.
Read the detailed description
Pain catastrophizing-a negative cognitive and emotional process that involves helplessness, rumination, and magnification of pain complaints-is the most consistent psychosocial factor predicting deleterious outcomes in chronic musculoskeletal pain, including fibromyalgia. We will use real-time functional magnetic resonance imaging (fMRI) neurofeedback as a research probe to elucidate the neurological mechanisms underlying self-regulation of pain catastrophizing in individuals with fibromyalgia.
Investigators will recruit patients diagnosed with fibromyalgia. In the baseline magnetic resonance imaging (MRI) visit, participants will complete a fMRI neurofeedback session inside an MRI scanner. Prior to entering the scanner, participants will complete several questionnaires and discuss with the research team the self-regulation strategies they plan to use during the neurofeedback task to modulate fibromyalgia pain. For the neurofeedback, participants will be presented with a visual representation of their brain activity performance so that they can maintain or update their strategy throughout the run. As part of the baseline visit, investigators will also apply moderate pressure pain to the patient's leg in the scanner to see how their brain responds to the experimental pain stimulation.
After the baseline visit, participants will be randomly assigned into the Cognitive Behavioral Therapy (CBT) or Fibromyalgia Education groups, and they will then attend 8 weekly intervention sessions with a pain psychologist. During the post-intervention MRI visit, participants will complete the same questionnaires and tasks performed at the baseline visit to assess changes in neural mechanisms underlying the self-regulation of fibromyalgia pain and the experience of experimental pain. All outcome measures will be assessed at both baseline and post-intervention visits.
- Conditions
- Fibromyalgia
- Being tested
- Cognitive Behavioral Therapy, Disease Education
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Practicing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain.
Disease EducationBehavioural
Providing information about fibromyalgia, including its potential causes and management approaches.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | 8 individual weekly visits with a psychologist for pain-related CBT. Receives: Behavioral: Cognitive Behavioral Therapy |
| Disease Education | Active comparator | 8 individual weekly visits with a psychologist for fibromyalgia education (this is an active comparator arm, matched for provider contact). Receives: Behavioral: Disease Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in brain activity in pain-associated regions such as vPCC/RSC
Changes in brain activity in pain-associated regions such as vPCC (ventral posterior cingulate cortex)/RSC (retrosplenial cortex), quantified as z-scores, during the self-regulation period of the MRI scan.
Measured: Brain activity data will be collected at baseline and at post-treatment, spanning approximately 4 months.
Secondary outcomes (2)
Pain Catastrophizing Scale (PCS)
Pain catastrophizing will be assessed with the Pain Catastrophizing Scale (PCS).
Pain Catastrophizing Scale (PCS) is a validated survey instrument that assesses the extent of catastrophizing thinking related to pain. Pain catastrophizing is assessed on a scale from 0 to 52, with higher scores indicating a higher levels of catastrophizing.
Measured: PCS will be assessed at baseline and at post-treatment, spanning approximately 4 months.
Brief Pain Inventory (BPI)
Brief Pain Inventory (BPI) is a validated questionnaire designed to assess the severity and interference of pain experienced. Pain severity is assessed on a scale from 0 (no pain) to 10 (severe pain). Pain interference is assessed on a scale from 0 (no interference) to 10 (severe interference).
Measured: BPI will be assessed at baseline and at post-treatment, spanning approximately 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start31 Oct 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Spaulding Rehabilitation Hospital
- Responsible party
- Principal investigator, Robert Edwards, Brigham and Women's Hospital
- Investigators
- Jeungchan Lee, PhD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023523
- Sponsor's protocol ID
- 2009P001021-R21
- Other IDs
- R21AR084246
- Status last verified
- Oct 2026
- First submitted
- 3 Jun 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-regulation of Real-time fMRI Brain Activity in Chronic Pain: A Potential Neurobiological Mechanism of Cognitive Behavioral Therapy
- ClinicalTrials.gov ID
- NCT07023523
- Acronym / sponsor ID
- 2009P001021-R21
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Spaulding Rehabilitation Hospital
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 17 Jun 2025 (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 explore the usefulness of self-regulation of brain activity in patients with fibromyalgia. Patients will use real-time functional magnetic resonance imaging (fMRI) neurofeedback to observe and regulate their own brain activity while applying mental strategies to reduce fibromyalgia pain. The study consists of 2 magnetic resonance imaging (MRI) visits that involve brain neuroimaging for fMRI neurofeedback tasks, as well as 8 weekly intervention sessions with a pain psychologist. Patients will be randomized to either Cognitive Behavioral Therapy (CBT) or Fibromyalgia Education groups.
Detailed description
Pain catastrophizing-a negative cognitive and emotional process that involves helplessness, rumination, and magnification of pain complaints-is the most consistent psychosocial factor predicting deleterious outcomes in chronic musculoskeletal pain, including fibromyalgia. We will use real-time functional magnetic resonance imaging (fMRI) neurofeedback as a research probe to elucidate the neurological mechanisms underlying self-regulation of pain catastrophizing in individuals with fibromyalgia.
Investigators will recruit patients diagnosed with fibromyalgia. In the baseline magnetic resonance imaging (MRI) visit, participants will complete a fMRI neurofeedback session inside an MRI scanner. Prior to entering the scanner, participants will complete several questionnaires and discuss with the research team the self-regulation strategies they plan to use during the neurofeedback task to modulate fibromyalgia pain. For the neurofeedback, participants will be presented with a visual representation of their brain activity performance so that they can maintain or update their strategy throughout the run. As part of the baseline visit, investigators will also apply moderate pressure pain to the patient's leg in the scanner to see how their brain responds to the experimental pain stimulation.
After the baseline visit, participants will be randomly assigned into the Cognitive Behavioral Therapy (CBT) or Fibromyalgia Education groups, and they will then attend 8 weekly intervention sessions with a pain psychologist. During the post-intervention MRI visit, participants will complete the same questionnaires and tasks performed at the baseline visit to assess changes in neural mechanisms underlying the self-regulation of fibromyalgia pain and the experience of experimental pain. All outcome measures will be assessed at both baseline and post-intervention visits.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral Therapy8 individual weekly visits with a psychologist for pain-related CBT. |
| Disease Education | Active comparator | Behavioral: Disease Education8 individual weekly visits with a psychologist for fibromyalgia education (this is an active comparator arm, matched for provider contact). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-65
- Meet the Wolfe et al 2011 research criteria for fibromyalgia for at least one year
- On stable doses of medication prior to entering the study and agree not to change medications or dosages (or CAM treatments) during the trial
- Baseline pain intensity of at least 4/10 on average and pain report for at least 50% of days
- Able to provide written consent and fluent in English
Key exclusion criteria (17 listed)
- Comorbid acute pain condition
- Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
- Stimulant medications for the fatigue associated with sleep apnea or shift work (e.g., modafinil),
- Pregnant or nursing
- Any psychiatric disorder involving a history of psychosis (e. g schizophrenia, severe personality disorders)
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 |
|---|---|---|
| Cognitive Behavioral TherapyPracticing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain. | Behavioural | Cognitive Behavioral Therapy |
| Disease EducationProviding information about fibromyalgia, including its potential causes and management approaches. | Behavioural | Disease Education |
Primary outcome
Changes in brain activity in pain-associated regions such as vPCC/RSC
Time frame: Brain activity data will be collected at baseline and at post-treatment, spanning approximately 4 months.
Changes in brain activity in pain-associated regions such as vPCC (ventral posterior cingulate cortex)/RSC (retrosplenial cortex), quantified as z-scores, during the self-regulation period of the MRI scan.
2 secondary outcomes
Pain Catastrophizing Scale (PCS)
Time frame: PCS will be assessed at baseline and at post-treatment, spanning approximately 4 months.
Brief Pain Inventory (BPI)
Time frame: BPI will be assessed at baseline and at post-treatment, spanning approximately 4 months.
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 5 Oct 2026.
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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.
Jeungchan Lee, PhD principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Disease Education in people with Fibromyalgia, run by Brigham and Women's Hospital at 1 site 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 5 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Soobin Choi, schoi38@mgb.org (617-952-6742, schoi38@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in brain activity in pain-associated regions such as vPCC/RSC (time frame: Brain activity data will be collected at baseline and at post-treatment, spanning approximately 4 months.). 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 5 Oct 2026.