Trial record 51 of 109 for:    fibromyalgia | Open Studies | Interventional Studies

A Brain Imaging Study of Fibromyalgia

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01857219
First received: December 6, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

Healthy adults and adults diagnosed with fibromyalgia, aged 18-50, are needed for a research study investigating whole brain functional Magnetic Resonance Imaging to assess cerebral blood flow and functional connectivity change in fibromyalgia patients.


Condition Intervention
Fibromyalgia
Radiation: fMRI

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Basic Science
Official Title: A Brain Imaging Study of Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Arterial spin labeling (ASL) [ Time Frame: single day ] [ Designated as safety issue: No ]
    A method to assess cerebral blood flow change (at rest) through functional magnetic resonance imaging.


Secondary Outcome Measures:
  • Resting-state BOLD fMRI [ Time Frame: single day ] [ Designated as safety issue: No ]
    A method to measure spontaneous brain activity fluctuations through functional magnetic resonance imaging.


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: fMRI
    functional magnetic resonance imaging
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Criteria for fibromyalgia patients.

Inclusion Criteria:

  • Volunteers 18-50 years of age.
  • Fibromyalgia for at least the past 3 months, as determined by the referring physician.
  • At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.

Exclusion Criteria:

  • Specific causes of pain (e.g., cancer, fractures, spinal stenosis, infections)
  • History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
  • Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.

Criteria for healthy adults.

Inclusion Criteria:

  • Volunteers 18-50 years of age.
  • At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.

Exclusion Criteria:

  • Chronic and acute pain (ex. Fibromyalgia).
  • History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
  • Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01857219

Contacts
Contact: Domenic Minicucci, BS 617-643-7947 dminicucci@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Domenic Minicucci, BS    617-643-7268    dminicucci@partners.org   
Principal Investigator: Jian Kong, MS, MPH         
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Jian Kong, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01857219     History of Changes
Other Study ID Numbers: 2012P002574
Study First Received: December 6, 2012
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
fMRI

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014