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Taking people in United StatesNo phase

Cognitive Training to Enhance Brain Concordance During Acupuncture

Key facts

Who runs it
Spaulding Rehabilitation Hospital
Where
Charlestown and Chestnut Hill, United StatesSee the 3 sites
Trial code
Status
Recruiting
People taking part
100 people, planned
Started
16 Feb 2024
Expected to end
30 Jun 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Electroacupuncture
  • Cognitive Training
  • Education Training
Record updated
24 October 2025

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 26 criteriaShow less

Who can take part

  • 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 take part

  • Concurrent inflammatory or autoimmune disease
  • Unwillingness to withhold from consuming marijuana 12 hours prior to scans
  • Unwillingness to withhold from consuming nicotine 4 hours prior to scans
  • 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
  • Comorbid acute pain condition
  • Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
  • 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
  • Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator would prevent satisfactory completion of the study protocol
  • Recent history of formal meditation-based training
  • Any longer period of work experience involving pain treatment, pain rehabilitation etc
  • 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
  • Current use of opioid analgesics
  • Documented peripheral neuropathy
  • Pregnant
  • Is an actual clinical patient of the clinician subject

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in United States

  • Massachusetts General HospitalCharlestown, United StatesContact: Seneca EllisTaking people
  • Spaulding Rehabilitation HospitalCharlestown, United StatesContact: Seneca EllisTaking people
  • Brigham and Women's HospitalChestnut Hill, United StatesContact: Seneca EllisTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Cognitive TrainingTreatment being tested

    Participants will meet with a pain specialist who will conduct a specific form of cognitive training targeting fibromyalgia.

    Treatment: Electroacupuncture and Cognitive Training

  • Education TrainingExisting treatment, for comparison

    Participants will meet with a pain specialist to receive education training related to fibromyalgia.

    Treatment: Electroacupuncture and Education Training

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Cognitive Training to Enhance Brain-to-brain Concordance During Acupuncture
Fit questions
Built from NCT06157866, who can take part
Publications
Record updated
24 October 2025