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

NCT05978830 | Unknown DMC

• 1 other identifier: Diagnosis and prognosis of AD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Keywords

EEG; MRI; Digital intelligence equipment; Machine learning; microstate

Outcome Measures

Primary Outcomes (5)

• 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.

  6 months

• 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.

  6 months

• 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.

  6 months

• 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.

  6 months

• 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.

  6 months

Study Arms (2)

Group 1

EXPERIMENTAL

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

Device: Transcranial ultrasound stimulation

Group 2

SHAM COMPARATOR

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

Device: Transcranial ultrasound stimulation

Interventions

Transcranial ultrasound stimulation DEVICE

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.

Group 1; Group 2

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

Yi Ling

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• benyan luo, Pro

  Department of Neurology, First Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Yi Ling, Dr

CONTACT

15168236137; 12118458@zju.edu.cn

Fangping He

CONTACT

13819114225

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study is double-blinded, meaning both participant and Investigator are unaware of the treatment received by the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 7, 2023
• Study Start: March 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: August 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)