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Clinical Trials/NCT05978830
NCT05978830
Recruiting
Not Applicable

The Development of Early-stage Alzheimer's Disease Multimodal Fusion Warning System and Non-invasive Neurostimulation Techniques.

First Affiliated Hospital of Zhejiang University1 site in 1 country100 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer's Disease
Sponsor
First Affiliated Hospital of Zhejiang University
Enrollment
100
Locations
1
Primary Endpoint
Duration of microstate
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Developing and validating an early digitalized recognition device and multimodal warning model for Alzheimer's disease, and establishing a precision transcranial ultrasound stimulation intervention system.

Detailed Description

1. Establishment of early digitalized recognition devices and multimodal warning models for AD: Participants undergo clinical assessments, and if they meet the inclusion criteria, their gender, age, MMSE, MoCA, CDR, GDS scores, as well as EEG ERP and MR data are collected. Eye-tracking analysis based on human-computer interaction perception technology, limb movement detection, and laser radar depth sensor fusion cognitive assessment are also performed simultaneously. After enrollment, follow-up assessments using scales (MMSE, MoCA, CDR, GDS, ADAS-cog, etc.) are conducted every six months, and EEG ERP and MR data are collected annually. 2. Construction of a precision transcranial ultrasound stimulation intervention system: Participants were randomly divided into true stimulation group and false stimulation group: true/false stimulation for 2 weeks, washout for 2 weeks, false/true stimulation for 2 weeks. After treatment, behavioral scale assessment, EEG ERP and multimodal MRI were performed to evaluate the therapeutic effect.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
December 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
First Affiliated Hospital of Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with MCI / AD
  • Between the ages of 55 and 80
  • No history of mental illness such as schizophrenia, severe anxiety and depression

Exclusion Criteria

  • Consistent with Parkinson's disease, frontotemporal dementia, dementia with lewy bodies Or Huntington's disease diagnostic criteria
  • Dementia due to other causes (e.g. cerebrovascular disease, central nervous system trauma, tumors, infections, Metabolic diseases, normal stress hydrocephalus, folic acid or vitamin B12 deficiency, hypothyroidism, etc.)
  • Have aphasia,Disorders that affect cognitive assessment, such as disorders of consciousness
  • Have a history of epilepsy or take antiepileptic drugs

Outcomes

Primary Outcomes

Duration of microstate

Time Frame: 6 months

The investigators refined the microstate method to accurately estimate topographical differences. The calculations were performed for measures of duration (ms). The duration of each microstate were utilized to predict disease classification and prognosis evaluation for patients with Alzheimer's disease.

Montreal Cognitive Assessment (MoCA)

Time Frame: 6 months

MoCA is a standardized assessment tool used to evaluate cognitive function, particularly for early cognitive impairment and mild cognitive impairment. It consists of a series of questions and tasks that cover areas such as memory, attention, executive functions, language, and spatial abilities. Test items include naming animals, drawing a clock, recalling a sequence, task guidance, etc., and each item is assigned a different score. The score range is from 0 to 30, with higher scores indicating better cognitive function.

Occurrence of microstate

Time Frame: 6 months

The investigators refined the microstate analysis. The calculations were performed for measures of occurrence (times per minute). The occurrence of microstates were utilized to predict disease classification and prognosis evaluation for patients with disturbance of consciousness.

Power spectrum

Time Frame: 6 months

The investigators collected EEG data of participants in resting state and listening to music and the absolute power spectral density values (alpha,beta,theta,delta bands dB/Hz) will be calculated using spectral analysis.

Mini-Mental State Examination (MMSE)

Time Frame: 6 months

MMSE includes a series of questions and tasks to assess the individual's memory, attention, calculation, language, spatial, and executive functions. The test items include recalling instructions, reproducing patterns, performing mathematical calculations, naming objects, writing sentences, etc. Each item has different scoring criteria, and scores are assigned based on the participant's responses and performance. The total score is 30, with higher scores indicating better cognitive functioning.

Study Sites (1)

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