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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02820974
• Other study ID #: NSFC81571656
• 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

• Acute Pain
• Menopause
• Migraine

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