Clinical trial NCT06157866: Cognitive Training to Enhance Brain Concordance During Acupuncture
Official title: Cognitive Training to Enhance Brain-to-brain Concordance During Acupuncture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: hyperscan fmri
hyperscan EEG
acupuncture
fibromyalgia
chronic pain
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-12-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

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

Primary outcomes:
measure: Brain Imaging-fMRI
timeFrame: Up to 6 months
Secondary outcomes:
measure: Brain Imaging-EEG
timeFrame: Up to 6 months
Other outcomes:
measure: Brief Pain Inventory (BPI) - Pain Interference
timeFrame: Up to 6 months
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Charlestown
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Vitaly Napadow, PhD
role: PRINCIPAL_INVESTIGATOR
References: