Brain MRI analysis for fibromyalgia patients

JRCT ID: jRCT1070230082

Registered date:05/11/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Fibromyalgia
• Date of first enrollment: 27/10/2023
• Target sample size: 26
• Study type: Interventional
• Intervention(s): multidisciplinary approach

Outcome(s)

Primary Outcome

1)Brain volume: Cortical and subcortical brain volume values for each brain region (mm3), (Anterior cingulate gyrus, Insura cortex, Prefrontal cortes, Hippocampal and Amygdala volume measurement)
2)Quantitative measure of nerve fiber bundles Fractional Anisotrophy
3)Resting-state functional brain network (connection of emotion-related circuits (correlation coefficient between anterior cingulate gyrus and insular gyrus), connection of descending inhibitory system (anterior cingulate gyrus-central gray matter and ventromedial medulla oblongata) correlation coefficient between parts), default mode network map)

Secondary Outcome

BPI, Brief Pain Inventory, Japanese version
PCS, Pain Catastrophizing Scale, Japanese version
PSEQ, Pain Self-Efficacy Questionnaire, Japanese version
HADS, Hospital Anxiety and Depression Sale, Japanese version

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Female

Include criteria

(1) Fibromyalgia cases: Diagnosed with Fibromyalgia according to the American College of Rheumatology (ACR) Fibromyalgia criteria (Wolfe et al., 2010), age 18 or older, younger than 75, and right-handed female.
(2) Healthy subjects: Those with no neuropsychiatric medical treatment or history, who scored in the healthy range on the Psychological Stress Response Scale (SRS-18), aged 18 to under 75, right-handed female.

• Exclude criteria: If contraindications for MRI apply (cardiac pacemaker, cerebral artery clipping surgery, internally implanted devices, etc., pregnant women, etc.)

Related Information

• Primary Sponsor: Sasara Takeshi