Alzheimer's DiseaseNCT05978830
Development of Multimodal Fusion Warning System and Non-invasive Techniques for Early Alzheimer's Detection.
A study testing Transcranial ultrasound stimulation in people with Alzheimer's Disease, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Transcranial ultrasound stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with MCI / AD
- Between the ages of 55 and 80
- No history of mental illness such as schizophrenia, severe anxiety and depression
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Fangping He contact
China1 site, 1 recruiting
- Recruiting
Yi Ling
Hangzhou, Zhejiang, 310000
Yi Ling, 15168236137, lywenzhoumc@163.com
About this study
Official title: The Development of Early-stage Alzheimer's Disease Multimodal Fusion Warning System and Non-invasive Neurostimulation Techniques.
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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Transcranial ultrasound stimulation
- Keywords
- EEG, MRI, Digital intelligence equipment, Machine learning, microstate
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial ultrasound stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | The group of subjects underwent active Transcranial ultrasound stimulation for 2 weeks Receives: Device: Transcranial ultrasound stimulation |
| Group 2 | Sham comparator | The group of subjects underwent sham Transcranial ultrasound stimulation for 2 weeks Receives: Device: Transcranial ultrasound stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Mar 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- benyan luo, Pro, Study chair, Department of Neurology, First Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978830
- Sponsor's protocol ID
- Diagnosis and prognosis of AD
- Status last verified
- Jul 2023
- First submitted
- 31 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Early-stage Alzheimer's Disease Multimodal Fusion Warning System and Non-invasive Neurostimulation Techniques.
- ClinicalTrials.gov ID
- NCT05978830
- Acronym / sponsor ID
- Diagnosis and prognosis of AD
- Conditions
- Alzheimer's Disease
- Keywords
- EEG, MRI, Digital intelligence equipment, Machine learning, microstate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Transcranial ultrasound stimulationThe group of subjects underwent active Transcranial ultrasound stimulation for 2 weeks |
| Group 2 | Sham comparator | Device: Transcranial ultrasound stimulationThe group of subjects underwent sham Transcranial ultrasound stimulation for 2 weeks |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with MCI / AD
- Between the ages of 55 and 80
- No history of mental illness such as schizophrenia, severe anxiety and depression
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial ultrasound stimulationIn 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. | Device | Group 1, Group 2 |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fangping He contact
benyan luo, Pro study chair
Department of Neurology, First Affiliated Hospital, School of Medicine, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial ultrasound stimulation in people with Alzheimer's Disease, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Ling, Dr (15168236137, 12118458@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power spectrum (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.