Interaction Research on Cognitive Impairment and Emotional Disorder in End-stage Renal Disease

• Conditions: Brain Damage; End-stage Kidney Disease

• Registration Number: NCT03191409
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

End stage renal disease (ESRD) is the last stage (stage 5) of chronic kidney disease (CKD). Abnormalities of cognitive function and high levels of depression or anxiety incidence are characteristic of hemodialysis patients. In this research project, the investigators subject in ESRD patients starting hemodialysis as the carrier. Based on the longitudinal research design, using multimodal neuroimaging data，combining with the interact relationship between changes of brain morphology, the dysfunction of resting-state and-task state with cognitive impairment and abnormal emotions.Establish brain structure-function change model associated with dialysis progression, Explore imaging markers of central and disease development characteristics in ESRD patients. the investigators attempt to clarify the core mechanism of kidney-brain axis damage, thus provide evidence for early cognitive-behavioral therapy to CKD patient.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-22
• Study Start: 2017-06-15
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-19
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-07-14
• Primary Completion: 2019-06-15
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age 18-50 years;
2. ESRD patients who will start hemodialysis
3. High quality MRI scan;
4. dextromanual

Exclusion Criteria

1. Diabetes,Brain tumor,brain trauma
2. Neuropsychiatric disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in cognitive function	Change from Baseline to 3 Months after dialysis	Cognitive testing will be performed for assessment

Secondary Outcome Measures

Name	Time	Method
Change in brain MRI	Change from Baseline to 3 Months after dialysis	Brain MRI will be performed before dialysis initiation and dialysis more than 3 months

Trial Locations

Locations (2)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 XI'an, Shaanxi, China

First affiliated hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China