Cognitive Training to Enhance Brain Concordance During Acupuncture

Official title

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

Overview

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.

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.

Interventions

• 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.
• Behavioral Education Training
  Education training with a pain specialist.

Primary outcome measures

• Brain Imaging-fMRI [Time frame: Up to 6 months]

Secondary outcome measures (1)

• Brain Imaging-EEG [Time frame: Up to 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Basic science

Study locations

United States · 3 centers

• Massachusetts General Hospital — Charlestown
• Spaulding Rehabilitation Hospital — Charlestown
• Brigham and Women's Hospital — Chestnut Hill

Identifiers

NCT: NCT06157866 · 2023P003155

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗