Cognitive Impairment in Hemodialysis Patients
Conditions
Interventions
Observation group:None
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Clearly diagnosed with end-stage renal disease (ESRD) according to clinical guidelines, currently undergoing regular maintenance hemodialysis for > 3 months (to ensure stable condition and dialysis regimen); 2. Baseline cognitive function assessed using the Montreal Cognitive Assessment (MoCA), with a score >= 26 after adjustment for education level (i.e., no cognitive impairment at baseline); 3. Aged between 18 and 80 years (inclusive). This range covers the main hemodialysis population while excluding very young patients (who may have unique etiologies) and very elderly patients (who often have multiple comorbidities and complex confounding factors). 4. Alert and oriented, with hearing, vision (correctable with reading glasses), and motor function sufficient to complete neuropsychological scale assessments and electroencephalography (EEG) examinations; 5. Fully understands the study's purpose, procedures, potential risks, and benefits, and has voluntarily provided written informed consent approved by the Ethics Committee; 6. A permanent resident of the local area with no plans to relocate within the next 2 years, ensuring ability to complete the planned follow-ups.
Exclusion criteria
Exclusion criteria: 1. History of severe neurological disorders: including a clear prior diagnosis of stroke (cerebral infarction or hemorrhage) with significant sequelae (e.g., hemiplegia, aphasia), brain tumor, epilepsy, head trauma leading to coma, central nervous system infection (e.g., meningitis, encephalitis), or Parkinson’s disease, as these conditions can directly cause cognitive impairment or significantly affect EEG background activity; 2. History of severe psychiatric disorders: such as major depressive episode, schizophrenia, bipolar disorder, or other severe mental illnesses, or current use of high-dose antipsychotic medications, as these conditions and medications can substantially impact cognitive function and EEG signals; 3. Diagnosed dementia or severe cognitive impairment: including a clinical diagnosis of Alzheimer’s disease, vascular dementia, Lewy body dementia, or any other type of dementia by a neurologist prior to baseline; or a MoCA score (education-adjusted) 3 months) regular use of medications with known significant effects on EEG (such as benzodiazepines, antiepileptic drugs, or central analgesics) that cannot be temporarily discontinued during the study; 7. Poor study compliance: including planned kidney transplantation or switch to peritoneal dialysis within the next 6 months; history of long-term alcohol abuse or substance use disorder; or any other condition considered by the investigator as likely to affect adherence to the study protocol or completion of scheduled follow-ups (e.g., long-term residence in another region, lack of stable contact information, severe agitation or uncooperativeness); 8. Other exclusions: pregnancy or lactation; any other special circumstances deemed by the investigator to make participation inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EEG: ?/ß Power Ratio (TBPR); Incident Cognitive Impairment (CI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Annualized Rate of Decline in MoCA Score;Longitudinal Changes in EEG Metrics; | — |
Countries
China
Contacts
Public ContactZhu Nan
Shanghai General Hospital
Outcome results
None listed