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Effectiveness and Safety of a Cognitive Training System for Patients with Mild Vascular Cognitive Impairment: A Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Trial

Effectiveness and Safety of a Cognitive Training System for Patients with Mild Vascular Cognitive Impairment: A Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110676
Enrollment
Unknown
Registered
2025-10-17
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Vascular mild cognitive impairment, VaMCI

Interventions

experimental group:System Name: Neurofeedback Cognitive Rehabilitation Training System Source: Shandong Haitian Intelligent Engineering Co., LTD Specification and Model: HTR-NJRZ-I
control group:Name: Cognitive Rehabilitation Training and Assessment Software Source: Produced by Hangzhou Jizhi Medical Technology Co., LTD. (Provided by Shandong Haitian Intelligent Engineering Co.,

Sponsors

The First Medical Center of the PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 85 years old; (2) Subjects who meet the diagnostic criteria for Vascular Cognitive Impairment (VCI) and are classified as having mild VCI according to the severity of cognitive impairment; (3) Montreal Cognitive Assessment (MoCA) score of less than 26 points during the screening period; (4) Clinical Dementia Rating (CDR) scale score of 0.5; (5) Having sufficient visual and auditory discrimination ability to undergo neuropsychological tests; (6) Subjects shall have a stable and reliable caregiver, or be able to contact the caregiver frequently (at least 10 hours per week or more). The caregiver shall assist the patient in participating in the entire research process, and must have sufficient interaction and communication with the patient to provide valuable information for the scoring of the subject's various mental status scales; (7) Having a certain educational level, and being able to read simple newspaper articles and write simple essays in the past; (8) Those who voluntarily participate in the clinical study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with memory deficits that appear early and deteriorate progressively, prominent Parkinson's disease features in the early stage, or primary neurological diseases (such as multiple sclerosis, encephalitis, etc.); (2) Patients with diseases that can explain cognitive impairment (e.g., brain tumors, poisoning), as well as systemic diseases and metabolic abnormalities that significantly affect cognitive function; (3) Patients with other diseases that interfere with the evaluation of cognitive function, including alcoholism (regular drinking with an average alcohol intake of >60g/day for men and >40g/day for women; calculation of alcohol amount: Alcohol amount (g) = Alcohol consumption (ml) × Alcohol content %(V/V) × 0.8 (g/ml)), drug addiction, or abuse of other psychotropic drugs; (4) Patients with severe abnormalities in cardiac, hepatic, or renal function (New York Heart Association (NYHA) classification of cardiac function >= Grade 3, or alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), or creatinine (Cr) levels exceeding 2.5 times the upper limit of the normal range); (5) Patients with implanted metal medical electronic devices in the body, such as cardiac pacemakers; (6) Patients with limited limb movement who cannot normally participate in cognitive function training; (7) Pregnant or lactating women; (8) Patients who cannot cooperate with treatment; (9) Patients who have participated in other interventional clinical studies within 3 months before screening; (10) Patients deemed unsuitable for enrollment by the researcher.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment Scale (MoCA);

Secondary

MeasureTime frame
Mini-Mental State Examination Score, MMSE;

Countries

China

Contacts

Public ContactZhao Dong

The First Medical Center of the PLA General Hospital

dong_zhaozhao@126.com+86 185 0017 7311

Outcome results

None listed

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