RECRUITING

Cognitive Training to Enhance Brain Concordance During Acupuncture

Conditions

Fibromyalgia hyperscan fmri hyperscan EEG acupuncture chronic pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Cognitive Training to Enhance Brain-to-brain Concordance During Acupuncture

Quick Facts

Study Start:2024-02-16

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06157866

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Seneca Ellis

CONTACT

617-952-6484

sellis11@mgb.org

Arvina Grahl, PhD

CONTACT

agrahl@mgh.harvard.edu

Principal Investigator

Vitaly Napadow, PhD

PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital

Study Locations (Sites)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129

United States

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129

United States

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467

United States

Collaborators and Investigators

Sponsor: Spaulding Rehabilitation Hospital

Vitaly Napadow, PhD, PRINCIPAL_INVESTIGATOR, Spaulding Rehabilitation Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-16

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-02-16

Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

hyperscan fmri
hyperscan EEG
acupuncture
fibromyalgia
chronic pain

Additional Relevant MeSH Terms

Fibromyalgia