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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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