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EEG-based cognitive impairment early screening -- a multi-center validation study

EEG-based cognitive impairment early screening -- a multi-center validation study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400094124
Enrollment
Unknown
Registered
2024-12-17
Start date
2024-12-20
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive disorder

Interventions

Gold Standard:MMSE or Montreal Cognitive Assessment Test (MoCA)
Index test:E-CDS (EEG - Cognitive Decline Screening) system

Sponsors

Shenzhen People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria of subjects with cognitive decline: 1) chief or bystander reported memory decline; 2) Over 50 years of age; 3) Right-handed; 4) Sign informed consent. The inclusion criteria of cognitively normal healthy control subjects were: 1) older than 50 years; 2) Right-handed; 3) Sign informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria for cognitive decline participants: 1) The presence of a major psychiatric disorder that causes cognitive impairment (such as depression, severe anxiety, severe sleep disorders, schizophrenia, etc.) or HAMA score >= 21 points (definitely severe anxiety) or HAMD score >= 20 points (may be mild to moderate depression) or PSQI score > 15 points; 2) The presence of a major neurological disorder that causes cognitive impairment (such as Lewy body dementia, frontotemporal dementia, Parkinson's disease, cerebral infarction, cerebral hemorrhage, brain injury, encephalitis, epilepsy, neurological syphilis, prion disease, brain tumors); 3) The presence of other pathological factors that cause cognitive impairment (such as severe anemia, severe renal and hepatic insufficiency, hypothyroidism, carbon monoxide poisoning, alcohol dependence, etc.); 4) Brain MRI shows the presence of cerebral infarction, Fazekas >= 2 white matter lesions, tumors or other significant abnormal signals; 5) Taking antidepressants, sedatives, or anti-epileptic drugs within the last 4 weeks before enrollment; 6) Severe cognitive impairment, language impairment, or inability to cooperate with assessment and testing. Exclusion criteria for cognitively healthy participants: 1) Self-reported memory problems; 2) The presence of one or more objective evidence of cognitive domain impairment, Moca = 2 white matter lesions, tumors, or other abnormal signals; 6) Taking anti-depressant or sedative medications that significantly affect brain function within the last 4 weeks prior to enrollment; 7) Combination of hypertension, diabetes, or other chronic conditions that affect the brain vasculature, or serious liver, kidney, cardiovascular, hematological, or other serious complications; 8) Subjects with alcohol or drug dependence; 9) Subjects who cannot cooperate with assessment and testing for various reasons.

Design outcomes

Primary

MeasureTime frame
Retest reliability;Multicenter outcome differences;Sensitivity;Specificity;Accuracy;

Secondary

MeasureTime frame
Average performance;

Countries

China

Contacts

Public ContactGuo Yi

Shenzhen People's Hospital

xuanyi_guo@163.com+86 139 0297 8692

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026