Recruiting

Cognitive TrainingCognitive Training to Enhance Brain Concordance During Acupuncture

Sponsor:

Spaulding Rehabilitation Hospital

Code:

NCT06157866

Conditions

Fibromyalgia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Electroacupuncture

Cognitive Training

Education Training

Study Details

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.

Conditions

Fibromyalgia

Study ID

NCT06157866

Start date

Feb 16, 2024

Status verified date

Oct, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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

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.

Cognitive Training

Cognitive training with a pain specialist.

Education Training

Education training with a pain specialist.

Primary outcome measure

Brain Imaging-fMRI [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Seneca Ellis

617-952-6484 sellis11@mgb.org

Arvina Grahl, PhD

agrahl@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

Seneca Ellis

617-952-6484 sellis11@mgb.org

Lara Gardiner

617-952-6483 lgardiner1@mgb.org

Spaulding Rehabilitation Hospital

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

Seneca Ellis

617-952-6484 sellis11@mgb.org

Lara Gardiner

617-952-6483 lgardiner1@mgb.org

Principal Investigator:

Vitaly Napadow, PhD

Brigham and Women's Hospital

Recruiting

Chestnut Hill, Massachusetts, United States, 02467

Contacts

Seneca Ellis

617-952-6484 sellis11@mgb.org

Lara Gardiner

617-952-6483 lgardiner1@mgb.org

More Information

Sponsor

Spaulding Rehabilitation Hospital

Last update posted

Oct 24, 2025

Last verified

Oct, 2025

Keywords

hyperscan fmri
hyperscan EEG
acupuncture
fibromyalgia
chronic pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital on 2025-10-24.