FibromyalgiaNCT06157866
Cognitive Training to Enhance Brain Concordance During Acupuncture
A study testing Electroacupuncture, Cognitive Training and Education Training in people with Fibromyalgia, run by Spaulding Rehabilitation Hospital at 3 sites in United States.
Trial summary
This study will evaluate the impact of a novel non-pharmacological multimodal therapy, a type of approach known to improve pain outcomes and recommended by the Institute of Medicine report for chronic pain management. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Electroacupuncture, Cognitive Training and Education Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Feb 2024to 30 Jun 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
- Meet traditional American College of Rheumatology (ACR) criteria for FM as well as the more recent Wolfe et al 2011 criteria
- Are on stable doses of medication for 30 days prior to entering the study and agree not to change medications or dosages during the trial
- Ability to fully understand and consent to study procedures
- Baseline pain intensity of at least 4/10
- Pain duration of at least 6 months
Who cannot join
- Any longer period of work experience involving pain treatment, pain rehabilitation etc.
- Presence of any illness that is judged to interfere with the trial. For example: psychiatric disorder according to the DSM-IV manual
- Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
- History of significant head injury
- Inability to respond accurately to the pain-relieving intervention in the behavioral part of the experiment, indicating a lack of response to the expectancy manipulation. If the healthy volunteer or clinician is not a responder to the behavioral expectancy induction he or she will be excluded.
- Unwillingness to receive brief experimental pain.
Show all 21Show fewer
- Leg pain or health issues that may interfere with the study procedures.
- Comorbid acute pain condition
- Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
- Current use of opioid analgesics
- Concurrent inflammatory or autoimmune disease
- Documented peripheral neuropathy
- Pregnant
- Any psychiatric disorder involving a history of psychosis (e. g schizophrenia, bipolar disorder, severe personality disorders)
- History of anxiety disorders or significant anxiety symptoms interfering with fMRI procedures (e.g., panic)
- Psychiatric hospitalization in the past 6 months
- Unwillingness to withhold from consuming marijuana 12 hours prior to scans
- Unwillingness to withhold from consuming nicotine 4 hours prior to scans
- Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator would prevent satisfactory completion of the study protocol.
- Is an actual clinical patient of the clinician subject
- Recent history of formal meditation-based training
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Arvina Grahl, PhD contact
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
Seneca Ellis, 617-952-6484, sellis11@mgb.org
Lara Gardiner, 617-952-6483, lgardiner1@mgb.org
- Recruiting
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129
Seneca Ellis, 617-952-6484, sellis11@mgb.org
Lara Gardiner, 617-952-6483, lgardiner1@mgb.org
- Recruiting
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
Seneca Ellis, 617-952-6484, sellis11@mgb.org
Lara Gardiner, 617-952-6483, lgardiner1@mgb.org
About this study
Official title: Cognitive Training to Enhance Brain-to-brain Concordance During Acupuncture
This study will evaluate the impact of a novel non-pharmacological multimodal therapy, a type of approach known to improve pain outcomes and recommended by the Institute of Medicine report for chronic pain management. This study design will also allow the investigators to evaluate a neural model supporting therapeutic alliance for pain outcomes for fibromyalgia.
Read the detailed description
The patient-clinician interaction is central to most therapies and is supported by key interpersonal mechanisms of action such as clinician empathy, therapeutic alliance, and trust. However, the neural underpinnings of this effect are mostly unknown. The investigators' recently published study applied functional MRI (fMRI) hyperscanning (i.e. simultaneously neuroimaging chronic pain patients and clinicians in synchronized MRI scanners) demonstrated that brain-to-brain concordance in the temporoparietal junction (TPJ) is up-regulated following a clinical interaction and associated with patient analgesia. Fibromyalgia is a chronic pain disorder in great need of novel therapies. This study will evaluate the impact of a novel multimodal therapy, a type of approach known to improve pain outcomes and recommended by the Institute of Medicine report for chronic pain management. The study design will also allow the investigators to evaluate a neural model supporting therapeutic alliance for pain outcomes for fibromyalgia wherein training and acupuncture will synergistically target a critical therapeutic pathway - i.e., patient-provider alliance, instantiated by TPJ concordance.
- Conditions
- Fibromyalgia
- Being tested
- Electroacupuncture, Cognitive Training, Education Training
- Keywords
- hyperscan fmri, hyperscan EEG, acupuncture, fibromyalgia, chronic pain
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureOther
During the treatment sessions the acupuncturist will insert needles in several locations aimed to reduce the patient's fibromyalgia pain. A low-amplitude, sub-sensory electrical current will be activated by the acupuncturist.
Cognitive TrainingBehavioural
Cognitive training with a pain specialist.
Education TrainingBehavioural
Education training with a pain specialist.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Participants will meet with a pain specialist who will conduct a specific form of cognitive training targeting fibromyalgia. Receives: Other: Electroacupuncture; Behavioral: Cognitive Training |
| Education Training | Active comparator | Participants will meet with a pain specialist to receive education training related to fibromyalgia. Receives: Other: Electroacupuncture; Behavioral: Education Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Imaging-fMRI
Hyperscan fMRI assessing brain-to-brain concordance between the patient and the clinician.
Measured: Up to 6 months
Secondary outcomes (1)
Brain Imaging-EEG
Hyperscan EEG assessing brain-to-brain concordance between the patient and the clinician.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start16 Feb 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Vitaly Napadow, LICAC, PhD, Spaulding Rehabilitation Hospital
- Investigators
- Vitaly Napadow, PhD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157866
- Sponsor's protocol ID
- 2023P003155
- Status last verified
- Oct 2025
- First submitted
- 5 Nov 2023
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Per NIH guidelines
Publications
Yamin JB, Grahl A, Anzolin A, Doan TDN, Ellis S, Gardiner L, Hewardt I, Lee SA, Lee J, Kelley JM, Kaptchuk T, Napadow V, Edwards RR. Mentalizing & InteRpersonal Recognition of Others' Relational States (MIRROR): a patient-directed intervention for navigating clinical encounters in chronic pain. Pain Manag. 2026 Sep 28:1-14. doi: 10.1080/17581869.2026.2740677. Online ahead of print.
PubMed 42803703
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training to Enhance Brain-to-brain Concordance During Acupuncture
- ClinicalTrials.gov ID
- NCT06157866
- Acronym / sponsor ID
- 2023P003155
- Conditions
- Fibromyalgia
- Keywords
- hyperscan fmri, hyperscan EEG, acupuncture, fibromyalgia, chronic pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Dec 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 will evaluate the impact of a novel non-pharmacological multimodal therapy, a type of approach known to improve pain outcomes and recommended by the Institute of Medicine report for chronic pain management. This study design will also allow the investigators to evaluate a neural model supporting therapeutic alliance for pain outcomes for fibromyalgia.
Detailed description
The patient-clinician interaction is central to most therapies and is supported by key interpersonal mechanisms of action such as clinician empathy, therapeutic alliance, and trust. However, the neural underpinnings of this effect are mostly unknown. The investigators' recently published study applied functional MRI (fMRI) hyperscanning (i.e. simultaneously neuroimaging chronic pain patients and clinicians in synchronized MRI scanners) demonstrated that brain-to-brain concordance in the temporoparietal junction (TPJ) is up-regulated following a clinical interaction and associated with patient analgesia. Fibromyalgia is a chronic pain disorder in great need of novel therapies. This study will evaluate the impact of a novel multimodal therapy, a type of approach known to improve pain outcomes and recommended by the Institute of Medicine report for chronic pain management. The study design will also allow the investigators to evaluate a neural model supporting therapeutic alliance for pain outcomes for fibromyalgia wherein training and acupuncture will synergistically target a critical therapeutic pathway - i.e., patient-provider alliance, instantiated by TPJ concordance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Other: Electroacupuncture, Behavioral: Cognitive TrainingParticipants will meet with a pain specialist who will conduct a specific form of cognitive training targeting fibromyalgia. |
| Education Training | Active comparator | Other: Electroacupuncture, Behavioral: Education TrainingParticipants will meet with a pain specialist to receive education training related to fibromyalgia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet traditional American College of Rheumatology (ACR) criteria for FM as well as the more recent Wolfe et al 2011 criteria
- Are on stable doses of medication for 30 days prior to entering the study and agree not to change medications or dosages during the trial
- Ability to fully understand and consent to study procedures
- Baseline pain intensity of at least 4/10
- Pain duration of at least 6 months
Key exclusion criteria (21 listed)
- Any longer period of work experience involving pain treatment, pain rehabilitation etc.
- Presence of any illness that is judged to interfere with the trial. For example: psychiatric disorder according to the DSM-IV manual
- Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
- History of significant head injury
- Inability to respond accurately to the pain-relieving intervention in the behavioral part of the experiment, indicating a lack of response to the expectancy manipulation. If the healthy volunteer or clinician is not a responder to the behavioral expectancy induction he or she will be excluded.
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 |
|---|---|---|
| ElectroacupunctureDuring the treatment sessions the acupuncturist will insert needles in several locations aimed to reduce the patient's fibromyalgia pain. A low-amplitude, sub-sensory electrical current will be activated by the acupuncturist. | Other | Cognitive Training, Education Training |
| Cognitive TrainingCognitive training with a pain specialist. | Behavioural | Cognitive Training |
| Education TrainingEducation training with a pain specialist. | Behavioural | Education Training |
Primary outcome
Brain Imaging-fMRI
Time frame: Up to 6 months
Hyperscan fMRI assessing brain-to-brain concordance between the patient and the clinician.
1 secondary outcome
Brain Imaging-EEG
Time frame: Up to 6 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 24 Oct 2025.
- Derived from this study: PubMed 42803703Yamin JB, Grahl A, Anzolin A, Doan TDN, Ellis S, Gardiner L, Hewardt I, Lee SA, Lee J, Kelley JM, Kaptchuk T, Napadow V, Edwards RR. Mentalizing & InteRpersonal Recognition of Others' Relational States (MIRROR): a patient-directed intervention for navigating clinical encounters in chronic pain. Pain Manag. 2026 Sep 28:1-14. doi: 10.1080/17581869.2026.2740677. Online ahead of print.
- Individual participant dataSharing planned: No. Per NIH guidelines
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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.
Arvina Grahl, PhD contact
Vitaly Napadow, PhD principal investigator
Spaulding Rehabilitation Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture, Cognitive Training and Education Training in people with Fibromyalgia, run by Spaulding Rehabilitation Hospital at 3 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 5 inclusion and 21 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 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Contact Seneca Ellis (617-952-6484, sellis11@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Imaging-fMRI (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06157866, which also lists 1 linked publication.
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 24 Oct 2025.