The Functional Magnetic Resonance Imaging Study on the Processing of Acute Pain and Cognition Among Perimenopause Women

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.

Study Overview

• Status: Unknown
• Conditions: Migraine; Menopause

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

25 years old or above, healthy women from the Department of orthopedics and medical center

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Healthy control; Healthy women of child bearing age (25-39) with regular cycles.
Perimenopause; Women at the age of 40-54 with irregular cycles filling in th criteria of perimenopause.
Menopause; Women at the age of over 55 without normal cycles filling in th criteria of menopause.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mean diffusivity	2-3 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Acute pain responses represented by Visual Analogue score	2-3 days
fractional anisotropy	2-3 days
mean kurtosis	2-3 days
cerebral blood flow	2-3 days
functional and structural connectivity	2-3 days

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: May 12, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): July 1, 2016

Study Record Updates

• Last Update Posted (Estimate): July 1, 2016
• Last Update Submitted That Met QC Criteria: June 28, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: NSFC81571656

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES