Cognitive Training and Electroacupuncture for Fibromyalgia

This study is looking at how a combination of Electroacupuncture (a treatment where thin needles are inserted into the skin and a low electrical current is applied) and Cognitive Training (working with a pain specialist to learn new ways of thinking about pain) might help people with fibromyalgia. You might be able to join if you are between 18 and 65 years old, have been diagnosed with fibromyalgia, and have a pain intensity of at least 4 out of 10. The researchers want to see if these treatments can change how your brain works, specifically by looking at brain imaging (fMRI) up to 6 months after the study starts. The study is currently unclear about its recruitment status.

Study design
This interventional study plans to enroll 100 participants. It is testing a combination of Electroacupuncture and Cognitive Training.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your brain activity will be measured using fMRI up to 6 months after the study begins.

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NCT06157866

Cognitive Training to Enhance Brain Concordance During Acupuncture

Recruiting
NAAges 18–65InterventionalBasic science
Spaulding Rehabilitation Hospital
~100 participants
Updated 2025-10-24 on ClinicalTrials.gov
What's tested:ElectroacupunctureCognitive TrainingEducation Training

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Brain Imaging-fMRI
Measured over Up to 6 months
Fibromyalgia
3 sites across 1 states
Massachusetts3
  • Vitaly Napadow, PhD · PRINCIPAL_INVESTIGATOR · Spaulding Rehabilitation Hospital

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.
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
  • Brain Imaging-fMRIUp to 6 months

    Hyperscan fMRI assessing brain-to-brain concordance between the patient and the clinician.