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Development of Multimodal Fusion Warning System and Non-invasive Techniques for Early Alzheimer's Detection.

Primary Purpose

Alzheimer's Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcranial ultrasound stimulation
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring EEG, MRI, Digital intelligence equipment, Machine learning, microstate

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yi LingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Group 1

Group 2

Arm Description

The group of subjects underwent active Transcranial ultrasound stimulation for 2 weeks

The group of subjects underwent sham Transcranial ultrasound stimulation for 2 weeks

Outcomes

Primary Outcome Measures

Power spectrum
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.
Duration of microstate
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.
Occurrence of microstate
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.
Mini-Mental State Examination (MMSE)
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.
Montreal Cognitive Assessment (MoCA)
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.

Secondary Outcome Measures

Full Information

First Posted
July 31, 2023
Last Updated
July 31, 2023
Sponsor
First Affiliated Hospital of Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05978830
Brief Title
Development of Multimodal Fusion Warning System and Non-invasive Techniques for Early Alzheimer's Detection.
Official Title
The Development of Early-stage Alzheimer's Disease Multimodal Fusion Warning System and Non-invasive Neurostimulation Techniques.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
EEG, MRI, Digital intelligence equipment, Machine learning, microstate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cognitive assessment was performed by neuropsychological professionals before and after each treatment, and treatment was performed with real and fake stimuli Multimodal MRI was performed again 2 days later. (1) Subjects in one group received Active Transcranial ultrasound stimulation for 2 weeks ; The other group received Sham Transcranial ultrasound stimulation for 2 weeks.
Masking
ParticipantInvestigator
Masking Description
The study is double-blinded, meaning both participant and Investigator are unaware of the treatment received by the patients.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
The group of subjects underwent active Transcranial ultrasound stimulation for 2 weeks
Arm Title
Group 2
Arm Type
Sham Comparator
Arm Description
The group of subjects underwent sham Transcranial ultrasound stimulation for 2 weeks
Intervention Type
Device
Intervention Name(s)
Transcranial ultrasound stimulation
Intervention Description
In each active/sham-ultrasound stimulation experiment, subjects first underwent two baseline motor evoked potential (MEP) tests, with an interval of 15 minutes between the two baseline tests. After 15 minutes of true/pseudo-transcranial ultrasound stimulation, subjects immediately underwent a MEP test, and then 15 minutes later, subjects underwent another MEP test. The MEP was tested again 15 minutes later.
Primary Outcome Measure Information:
Title
Power spectrum
Description
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.
Time Frame
6 months
Title
Duration of microstate
Description
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.
Time Frame
6 months
Title
Occurrence of microstate
Description
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.
Time Frame
6 months
Title
Mini-Mental State Examination (MMSE)
Description
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.
Time Frame
6 months
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Ling, Dr
Phone
15168236137
Email
12118458@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Fangping He
Phone
13819114225
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
benyan luo, Pro
Organizational Affiliation
Department of Neurology, First Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
Yi Ling
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Ling
Phone
15168236137
Email
lywenzhoumc@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Development of Multimodal Fusion Warning System and Non-invasive Techniques for Early Alzheimer's Detection.

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