Clinical trial NCT02820974: The Functional Magnetic Resonance Imaging Study on the Processing of Acute Pain and Cognition Among Perimenopause Women
Official title: The Functional Magnetic Resonance Imaging Study on the Processing of Acute Pain and Cognition Among Perimenopause Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Menopause
Migraine
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 150
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 25 years old or above, healthy women from the Department of orthopedics and medical center

Brief summary: There lacks effective early screen system for the migraine-susceptible women during the peri-menopause period. The processing of acute pain and cognition as well as the underling functional magnetic resonance imaging (fMRI) features are suitable for screening pain-susceptible individual. However, there is no study on this issue among the large sample peri-menopause women. The investigators thus designed the current trial to investigate the processing of acute pain and cognition as well as the underling featured functional magnetic resonance imaging (fMRI).The investigators will combine pain behavior,cognitive task, fMRI analysis, psychophysiological interaction (PPI) and suitable statistical package to investigate the relationship between the above mentioned features and the occurrence of migraine and then test the efficacy of these features in predicting migraine development. The investigators will then try to establish the screening system for migraine-susceptible individuals in peri-menopause women.

Detailed description: Although the prevalence of migraine is very high during peri-menopause period, there exist significant individual differences in whether developing migraine among this population. However, there still lacks effective early screen system for the migraine- susceptible women during the peri-menopause period. Individual acute pain processing and its interaction with cognition as well as the underling featured functional magnetic resonance imaging (fMRI) are suitable for screening pain-susceptible individual. Actually, the featured acute pain processing and its interaction with cognition as well as fMRI alterations were reported in two previous small sample trials among pre-menopause population, however, there is no similar study on large sample peri-menopause women. The investigators previously reported abnormal acute pain processing and decreased cognition in the experimental peri-menopause rats as well as peri-menopause women with migraine. The investigators thus raised the current hypothesis that the acute pain processing and its interaction with cognition as well as the underling featured functional magnetic resonance imaging (fMRI) are usable for screening migraine-susceptible individuals among peri-menopause women. In the current project, The investigators will combine pain behavior,cognitive task, fMRI analysis, psychophysiological interaction (PPI) and suitable statistical package to investigated the relationship between the above mentioned features and the occurrence of migraine and then test the efficacy of these features in predicting migraine development. The investigators will then try to establish the screening system for migraine-susceptible individuals in peri-menopause women.

Eligibility criteria: Inclusion Criteria:

* 25 years old or above
* Healthy women

Exclusion Criteria:

* Those with history of present illness
* Past history of significant neurological and psychiatric disorders or MRI contraindication

Primary outcomes:
measure: mean diffusivity
timeFrame: 2-3 days
Secondary outcomes:
measure: Acute pain responses represented by Visual Analogue score
timeFrame: 2-3 days
measure: fractional anisotropy
timeFrame: 2-3 days
measure: mean kurtosis
timeFrame: 2-3 days
measure: cerebral blood flow
timeFrame: 2-3 days
measure: functional and structural connectivity
timeFrame: 2-3 days
Other outcomes:
Locations:
Study officials:
References:
citation: Hu B, Yu Y, Dai YJ, Feng JH, Yan LF, Sun Q, Zhang J, Yang Y, Hu YC, Nan HY, Zhang XN, Zheng Z, Qin P, Wei XC, Cui GB, Wang W. Multi-modal MRI Reveals the Neurovascular Coupling Dysfunction in Chronic Migraine. Neuroscience. 2019 Nov 1;419:72-82. doi: 10.1016/j.neuroscience.2019.09.022. Epub 2019 Nov 1.
citation: Hu B, Wang X, He JB, Dai YJ, Zhang J, Yu Y, Sun Q, Lin-FengYan, Hu YC, Nan HY, Yang Y, Kaye AD, Cui GB, Wang W. Structural and functional brain changes in perimenopausal women who are susceptible to migraine: a study protocol of multi-modal MRI trial. BMC Med Imaging. 2018 Sep 6;18(1):26. doi: 10.1186/s12880-018-0272-6.
citation: Dai YJ, Zhang X, Yang Y, Nan HY, Yu Y, Sun Q, Yan LF, Hu B, Zhang J, Qiu ZY, Gao Y, Cui GB, Chen BL, Wang W. Gender differences in functional connectivities between insular subdivisions and selective pain-related brain structures. J Headache Pain. 2018 Mar 14;19(1):24. doi: 10.1186/s10194-018-0849-z.