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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02820974
Other study ID # NSFC81571656
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 12, 2016
Last updated June 28, 2016
Start date November 2016
Est. completion date December 2019

Study information

Verified date June 2016
Source Tang-Du Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date December 2019
Est. primary completion date June 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years and older
Eligibility 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 Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tang-Du Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary mean diffusivity 2-3 days Yes
Secondary Acute pain responses represented by Visual Analogue score 2-3 days Yes
Secondary fractional anisotropy 2-3 days Yes
Secondary mean kurtosis 2-3 days Yes
Secondary cerebral blood flow 2-3 days Yes
Secondary functional and structural connectivity 2-3 days Yes
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