Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06157866

Cognitive Training to Enhance Brain Concordance During Acupuncture

Led by Spaulding Rehabilitation Hospital · Updated on 2025-10-24

100

Participants Needed

3

Research Sites

175 weeks

Total Duration

On this page

Sponsors

S

Spaulding Rehabilitation Hospital

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cognitive Training to Enhance Brain Concordance During Acupuncture

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet traditional American College of Rheumatology (ACR) criteria for fibromyalgia and Wolfe et al 2011 criteria
  • On stable medication doses for at least 30 days before starting the study and agree not to change them during the trial
  • Able to fully understand and consent to study procedures
  • Baseline pain intensity of 4 or higher on a 0-10 scale
  • Pain lasting for at least 6 months
Not Eligible

You will not qualify if you...

  • Extensive prior work experience in pain treatment or rehabilitation
  • Any illness that may interfere with the study, including psychiatric disorders per DSM-IV
  • Contraindications to fMRI such as pacemakers, metal implants, claustrophobia, or pregnancy
  • History of significant head injury
  • Lack of response to the study's pain-relief behavioral intervention
  • Unwillingness to receive brief experimental pain
  • Leg pain or health issues interfering with study procedures
  • Other acute or chronic pain conditions rated as more painful than fibromyalgia
  • Current use of opioid pain medications
  • Inflammatory or autoimmune diseases
  • Documented peripheral neuropathy
  • Pregnancy
  • Psychiatric disorders involving psychosis history
  • Anxiety disorders or severe anxiety affecting fMRI participation
  • Psychiatric hospitalization within the past 6 months
  • Unwillingness to abstain from marijuana 12 hours before scans
  • Unwillingness to abstain from nicotine 4 hours before scans
  • Any impairment or situation preventing completion of the study
  • Being a current clinical patient of the clinician involved
  • Recent history of formal meditation-based training

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Massachusetts General Hospital

Charlestown, Massachusetts, United States, 02129

Actively Recruiting

2

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, United States, 02129

Actively Recruiting

3

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, United States, 02467

Actively Recruiting

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Research Team

S

Seneca Ellis

CONTACT

A

Arvina Grahl, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Cognitive Training to Enhance Brain Concordance During Acupuncture | DecenTrialz