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

End-stage Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03191409
• Other study ID #: 2015YK15
• Status: Recruiting
• Phase: N/A
• First received: June 22, 2016
• Last updated: July 12, 2017
• Start date: June 15, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2017
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Ming Zhang, Ph.D
• Phone: 18991232265
• Email: zmmri[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Damage
• Brain Injuries
• Cognition Disorders
• End-stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	XI'an	Shaanxi
China	First affiliated hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Xidian University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in cognitive function	Cognitive testing will be performed for assessment	Change from Baseline to 3 Months after dialysis
Secondary	Change in brain MRI	Brain MRI will be performed before dialysis initiation and dialysis more than 3 months	Change from Baseline to 3 Months after dialysis