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NCT Number: NCT06157866

Cognitive Training to Enhance 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Charlestown, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

electroacupuncture

Other

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

Behavioral

Cognitive training with a pain specialist.

Education Training

Behavioral

Education training with a pain specialist.

Primary outcomes

  1. Brain Imaging-fMRI

    Time frame: Up to 6 months

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

Secondary outcomes

  1. Brain Imaging-EEG

    Time frame: Up to 6 months

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

Other outcomes

  1. Brief Pain Inventory (BPI) - Pain Interference

    Time frame: Up to 6 months

    Brief Pain Inventory (BPI) is a validated 16 item questionnaire designed to assess the severity and interference of pain experienced. Pain interference is assessed on a scale from 0 (no interference) to 10 (severe interference).

Study contacts

Contact information is provided by the study sponsor or research team.

Arvina Grahl, PhD

CONTACT

[email protected]

Seneca Ellis

CONTACT

[email protected]

617-952-6484

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Cognitive Training to Enhance Brain-to-brain Concordance During Acupuncture

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 6, 2023
Registry last updated
Oct 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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