Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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