Cognitive Training to Enhance Brain Concordance During Acupuncture

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06157866
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Spaulding Rehabilitation Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Vitaly Napadow, PhD
Principal Investigator Affiliation Spaulding Rehabilitation Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Fibromyalgia
Additional Details

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.

Arms & Interventions

Arms

Experimental: Cognitive Training

Participants will meet with a pain specialist who will conduct a specific form of cognitive training targeting fibromyalgia.

Active Comparator: Education Training

Participants will meet with a pain specialist to receive education training related to fibromyalgia.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Massachusetts General Hospital, Charlestown, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Charlestown, Massachusetts, 02129

Site Contact

Seneca Ellis

[email protected]

617-952-6484

Spaulding Rehabilitation Hospital, Charlestown, Massachusetts

Status

Recruiting

Address

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129

Site Contact

Seneca Ellis

[email protected]

617-952-6484

Brigham and Women's Hospital, Chestnut Hill, Massachusetts

Status

Recruiting

Address

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467

Site Contact

Seneca Ellis

[email protected]

617-952-6484