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Trial record 115 of 138 for:    Recruiting, Not yet recruiting, Available Studies | "head injuries" NOT (traumatic OR concussion)

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

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ClinicalTrials.gov Identifier: NCT03191409
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : July 14, 2017
Sponsor:
Collaborator:
Xidian University
Information provided by (Responsible Party):
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.

Condition or disease
End-stage Kidney Disease Brain Damage

Study Type : Observational
Estimated 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 : June 15, 2017
Estimated Primary Completion Date : June 15, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. change in cognitive function [ Time Frame: Change from Baseline to 3 Months after dialysis ]
    Cognitive testing will be performed for assessment


Secondary Outcome Measures :
  1. Change in brain MRI [ Time Frame: Change from Baseline to 3 Months after dialysis ]
    Brain MRI will be performed before dialysis initiation and dialysis more than 3 months



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ESRD patients before dialysis initiation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191409


Contacts
Contact: Ming Zhang, Ph.D 18991232265 zmmri@163.com

Locations
China, Shaanxi
First Affiliated Hospital of Xi'an Jiaotong University Recruiting
XI'an, Shaanxi, China, 710061
Contact: Ming Zhang, Ph.D    18991232265    zmmri@163.com   
First affiliated hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Ming Zhang, Ph.D    18991232265    zmmri@163.com   
Principal Investigator: Dun Ding, MD         
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Xidian University

Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03191409     History of Changes
Other Study ID Numbers: 2015YK15
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
cognitive impairment
ESRD
functional MRI

Additional relevant MeSH terms:
Craniocerebral Trauma
Kidney Diseases
Cognitive Dysfunction
Kidney Failure, Chronic
Brain Injuries
Urologic Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Renal Insufficiency, Chronic
Renal Insufficiency
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries