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Cognitive Training to Enhance Brain Concordance During Acupuncture

NCT ID: NCT06157866
Registry status: Recruiting
Study type: Interventional
Phase: Not applicable
Sponsor: Spaulding Rehabilitation Hospital
Conditions: Fibromyalgia

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Cognitive Training to Enhance Brain-to-brain Concordance During Acupuncture

Enrollment: 100 participants (Estimated).

What is being studied

Intervention: Acupuncture Therapy
Intervention: Aftercare
Intervention: Analgesia
Intervention: Anesthesia
Intervention: Anesthesia and Analgesia
Intervention: Behavioral Disciplines and Activities
Intervention: Behavioral Sciences
Intervention: Cognitive Training
Behavioral: Cognitive Training
Intervention: Combined Modality Therapy
Intervention: Complementary Therapies
Intervention: Continuity of Patient Care
Behavioral: Education Training
Intervention: Electric Stimulation Therapy
Intervention: Electroacupuncture
Other: Electroacupuncture
Intervention: Health Care Facilities Workforce and Services
Intervention: Health Services
Intervention: Neurological Rehabilitation
Intervention: Patient Care
Intervention: Physical Therapy Modalities
Intervention: Rehabilitation
Intervention: Sex Education
Intervention: Sexology
Intervention: Therapeutics
Intervention: Transcutaneous Electric Nerve Stimulation

Who may be eligible

Ages: 18 Years to 65 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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

Study locations

3 study locations are listed.

Recruiting site status is explicitly provided for 3 locations; 3 are listed as Recruiting.

Countries: United States

Massachusetts, United States: 3

Sample of listed locations

Massachusetts General Hospital — Charlestown, Massachusetts, 02129, United States — Recruiting
Spaulding Rehabilitation Hospital — Charlestown, Massachusetts, 02129, United States — Recruiting
Brigham and Women's Hospital — Chestnut Hill, Massachusetts, 02467, United States — Recruiting

Study details

Start date: February 16, 2024
Primary completion date: June 30, 2027
Completion date: June 30, 2027
First posted: December 6, 2023
Collaborators: National Institutes of Health (NIH)

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06157866
Registry last updated: October 24, 2025
QualifiedStudies registry data refreshed: October 2, 2026
QualifiedStudies record fetched: October 2, 2026

View NCT06157866 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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