Cognitive Training to Enhance Brain Concordance During Acupuncture

Cognitive Training to Enhance Brain-to-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.

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Electroacupuncture; Behavioral: Cognitive Training; Behavioral: Education Training

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arvina Grahl, PhD; Email: agrahl@mgh.harvard.edu
• Study Contact Backup: Name: Seneca Ellis; Phone Number: 617-952-6484; Email: sellis11@mgb.org

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Seneca Ellis; Phone Number: 617-952-6484; Email: sellis11@mgb.org
      • Contact: Lara Gardiner; Phone Number: 617-952-6483; Email: lgardiner1@mgb.org
    • Charlestown, Massachusetts, United States, 02129
      • Recruiting
      • Spaulding Rehabilitation Hospital
      • Contact: Seneca Ellis; Phone Number: 617-952-6484; Email: sellis11@mgb.org
      • Contact: Lara Gardiner; Phone Number: 617-952-6483; Email: lgardiner1@mgb.org
      • Principal Investigator: Vitaly Napadow, PhD
    • Chestnut Hill, Massachusetts, United States, 02467
      • Recruiting
      • Brigham and Women's Hospital
      • Sub-Investigator: Robert Edwards, PhD
      • Contact: Seneca Ellis; Phone Number: 617-952-6484; Email: sellis11@mgb.org
      • Contact: Lara Gardiner; Phone Number: 617-952-6483; Email: lgardiner1@mgb.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Training; Participants will meet with a pain specialist who will conduct a specific form of cognitive training targeting fibromyalgia.	Other: 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.; Behavioral: Cognitive Training; Cognitive training with a pain specialist.
Active Comparator: Education Training; Participants will meet with a pain specialist to receive education training related to fibromyalgia.	Other: 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.; Behavioral: Education Training; Education training with a pain specialist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain Imaging-fMRI	Hyperscan fMRI assessing brain-to-brain concordance between the patient and the clinician.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain Imaging-EEG	Hyperscan EEG assessing brain-to-brain concordance between the patient and the clinician.	Up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory (BPI) - Pain Interference	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).	Up to 6 months

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Vitaly Napadow, PhD, Spaulding Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: November 5, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Estimated): October 24, 2025
• Last Update Submitted That Met QC Criteria: October 22, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: chronic pain; fibromyalgia; acupuncture; hyperscan fmri; hyperscan EEG
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fibromyalgia; Chronic Pain; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Patient Care; Health Services; Health Care Facilities Workforce and Services; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Anesthesia and Analgesia; Electric Stimulation Therapy; Neurological Rehabilitation; Combined Modality Therapy; Sexology; Behavioral Sciences; Anesthesia; Analgesia; Acupuncture Therapy; Transcutaneous Electric Nerve Stimulation; Cognitive Training; Sex Education; Electroacupuncture
• Other Study ID Numbers: 2023P003155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Per NIH guidelines

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No