Alzheimers disease
Conditions
Interventions
Single Group (Self-Control):taVNS intervention (transcutaneous auricular vagus nerve stimulation): device model tVNS501
parameters: frequency 20Hz, pulse width 300µs, biphasic sinusoidal pulsed current, stimulation cycle of 30s on/30s off
frequency: twice daily, 30 minutes per session
duration: continuous intervention for 28 days (5 consecutive days per week, total 20 sessions)
Sponsors
Second Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
55 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Normal communication ability; 2. Age range: 55-80 years old, gender; 3. Diagnosed with cognitive impairment according to clinical standard assessment. All participants underwent systematic clinical standard assessment, including cognitive function screening, potential etiology exclusion, and severity grading. The assessment was completed through the following 5 dimensions: medical history collection, physical examination, neuropsychological assessment, laboratory tests, and imaging examination. (1) Medical history collection Presence of cognitive decline, mild impairment in complex instrumental activities of daily living, and non-cognitive neuropsychiatric symptoms, such as apathy, depression, and anxiety; (2) Physical examination Abnormalities in consciousness, higher cortical function tests (remote and recent memory, comprehension, orientation, calculation, and judgment), cranial nerves, motor system (muscle bulk, muscle tone, muscle strength, involuntary movements, coordination, gait), sensory system (superficial sensation, deep sensation, composite sensation), reflexes (superficial reflexes, deep reflexes, pathological reflexes), and meningeal irritation signs; (3) Neuropsychological assessment According to the Addenbrooke's Cognitive Examination III (ACE-III) [13], cognitive impairment diagnostic cut-off scores vary by education level: 1-9 years of education, score 16 years of education, score < 80; Severity of cognitive impairment is graded using the Clinical Dementia Rating (CDR) scale: CDR = 0.5 indicates questionable dementia/mild cognitive impairment, CDR = 1.0 indicates mild dementia, CDR = 2.0 indicates moderate dementia, CDR = 3.0 indicates severe dementia; (4) Laboratory tests Detection of biomarkers related to cognitive impairment pathology; (5) Imaging examination Presence of characteristic patterns of hypometabolism and brain atrophy with disease-specific patterns that exceed normal age-related changes.
Exclusion criteria
Exclusion criteria: 1. Individuals with mental or psychological disorders who cannot sign the informed consent form or are unable to cooperate with the test; 2. Patients with cerebrovascular disease, tumours, infections, or autoimmune diseases; 3. Skin issues: skin infections, wounds, or other skin problems in areas where neurostimulation devices are applied; 4. Psychological dependence: history of substance abuse or alcohol dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| On the 28th day of continuous taVNS intervention, the difference in reaction time and accuracy of cognitive tests in subjects compared with baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference in HAMA scale scores from baseline was assessed in subjects on the first day of taVNS intervention;The difference in reaction time and accuracy of cognitive tests on the first day of taVNS intervention compared to baseline;Changes in key EEG features related to cognitive ability in subjects on the first day of taVNS intervention compared to baseline;Difference in HAMA scale assessment from baseline for subjects on the 28th day of taVNS intervention;Changes in key EEG features related to cognitive abilities in subjects on day 28 of taVNS intervention compared to baseline;The difference in HAMA scale scores from baseline to day 28 after the completion of taVNS intervention in subjects;The difference in reaction time and accuracy of participants' cognitive tests 28 days after the end of taVNS intervention compared to baseline;Changes in key EEG features related to cognitive ability in subjects on day 28 after the end of taVNS intervention compared with baseline; | — |
Countries
China
Contacts
Public ContactYang Hui
Second Affiliated Hospital of Army Medical University
Outcome results
None listed