Cognitive Training to Enhance Brain Concordance During Acupuncture

Last updated: February 22, 2024
Sponsor: Spaulding Rehabilitation Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Fibromyalgia

Treatment

Cognitive Training

Education Training

Electroacupuncture

Clinical Study ID

NCT06157866
2023P003155
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet traditional American College of Rheumatology (ACR) criteria for FM as well as themore recent Wolfe et al 2011 criteria
  • Are on stable doses of medication for 30 days prior to entering the study and agreenot 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

Exclusion Criteria:

  • Any longer period of work experience involving pain treatment, pain rehabilitationetc.
  • 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 behavioralpart 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 expectancyinduction 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 thanfibromyalgia
  • 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, bipolardisorder, severe personality disorders)
  • History of anxiety disorders or significant anxiety symptoms interfering with fMRIprocedures (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 orPrincipal 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

Study Design

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Cognitive Training
Phase:
Study Start date:
February 16, 2024
Estimated Completion Date:
June 30, 2027

Study Description

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.

Connect with a study center

  • Massachusetts General Hospital

    Charlestown, Massachusetts 02129
    United States

    Active - Recruiting

  • Spaulding Rehabilitation Hospital

    Charlestown, Massachusetts 02129
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Chestnut Hill, Massachusetts 02467
    United States

    Active - Recruiting

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