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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03191409

Collaborator

Xidian University (Other)

Enrollment

Locations

24.5

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End-stage Kidney Disease Brain Damage

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 15, 2017

Anticipated Primary Completion Date :

Jun 15, 2019

Anticipated Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Control Group Health adults with no evidence of brain lesions on conventional magnetic resonance imaging(MRI) and no neural developmental disorders.
Patients Group ESRD patients pre-hemodialysis will be collected.The following exclusion criteria were applied in this study: (a)history of drug or alcohol abuse, (b) brain lesions such as a tumor or stroke assessed on the basis of medical history, (c) history of or current psychiatric disorders, and (d) head motion more than 1.0 mm or 1.0°during magnetic resonance imaging. All patients completed laboratory tests to evaluate renal function,serum creatinine, and urea levels within the 12 hours before magnetic resonance imaging.

Arm

Intervention/Treatment

Control Group

Health adults with no evidence of brain lesions on conventional magnetic resonance imaging(MRI) and no neural developmental disorders.

Patients Group

ESRD patients pre-hemodialysis will be collected.The following exclusion criteria were applied in this study: (a)history of drug or alcohol abuse, (b) brain lesions such as a tumor or stroke assessed on the basis of medical history, (c) history of or current psychiatric disorders, and (d) head motion more than 1.0 mm or 1.0°during magnetic resonance imaging. All patients completed laboratory tests to evaluate renal function,serum creatinine, and urea levels within the 12 hours before magnetic resonance imaging.

Outcome Measures

Primary Outcome Measures

change in cognitive function [Change from Baseline to 3 Months after dialysis]
Cognitive testing will be performed for assessment

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age 18-50 years;
ESRD patients who will start hemodialysis
High quality MRI scan;
dextromanual

Exclusion Criteria:

Diabetes,Brain tumor,brain trauma
Neuropsychiatric disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Xi'an Jiaotong University	XI'an	Shaanxi	China	710061
2	First affiliated hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China	710061