Cognitive Training to Enhance Brain Concordance During Acupuncture
NCT ID: NCT06157866
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-02-16
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Cognitive Training
Participants will meet with a pain specialist who will conduct a specific form of cognitive training targeting fibromyalgia.
Electroacupuncture
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 Training
Cognitive training with a pain specialist.
Education Training
Participants will meet with a pain specialist to receive education training related to fibromyalgia.
Electroacupuncture
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.
Education Training
Education training with a pain specialist.
Interventions
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Electroacupuncture
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 Training
Cognitive training with a pain specialist.
Education Training
Education training with a pain specialist.
Eligibility Criteria
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Inclusion 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 Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Spaulding Rehabilitation Hospital
OTHER
Responsible Party
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Vitaly Napadow, LICAC, PhD
Professor
Principal Investigators
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Vitaly Napadow, PhD
Role: PRINCIPAL_INVESTIGATOR
Spaulding Rehabilitation Hospital
Locations
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Massachusetts General Hospital
Charlestown, Massachusetts, United States
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023P003155
Identifier Type: -
Identifier Source: org_study_id
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