Cognitive Training to Enhance Brain Concordance During Acupuncture

Part of paid clinical trials in Charlestown, Massachusetts.

Sponsor
Spaulding Rehabilitation Hospital
Study ID
NCT06157866
Status
Recruiting
Apply to this trial

Conditions

  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Electroacupuncture — OTHER
    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 — BEHAVIORAL
    Cognitive training with a pain specialist.
  • Education Training — BEHAVIORAL
    Education training with a pain specialist.

Study Details

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.

Key Dates

Start date
Feb 16, 2024
Status verified
Oct 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalCharlestownMassachusetts02129
Seneca Ellis
[email protected]
617-952-6484
Lara Gardiner
[email protected]
617-952-6483
Spaulding Rehabilitation HospitalCharlestownMassachusetts02129
Seneca Ellis
[email protected]
617-952-6484
Lara Gardiner
[email protected]
617-952-6483
Vitaly Napadow, PhD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalChestnut HillMassachusetts02467
Seneca Ellis
[email protected]
617-952-6484
Lara Gardiner
[email protected]
617-952-6483
Robert Edwards, PhD (SUB_INVESTIGATOR)

Find similar trials in Charlestown, MA

By research site
Massachusetts General Hospital· Charlestown, MASpaulding Rehabilitation Hospital· Charlestown, MABrigham and Women's Hospital· Chestnut Hill, MA

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