AgingNCT05967390
Localized Analysis of Normalized Distance From Scalp to Cortex and Personalized Evaluation (LANDSCAPE)
An observational study of Aging and Dementia Alzheimers, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Scalp to cortex distance (SCD), as a key technological parameter of brain stimulation, has been highlighted in the guidelines of non-invasive brain stimulation. However, in the context of age-related brain changes, the region-specific SCD and its impact on stimulation-induced electric field in different types of… Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Dementia Alzheimers, Parkinson Disease
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- How many people
- 488 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Jun 2023to 14 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy normal ageing adults and adults with neurocognitive disorders
Who may be able to join
- Right-handed as assessed by the Edinburgh Inventory
- Able to attend TMS interventions
- Consent
- Independent in daily life activities
Who cannot join
- Uncorrected visual or auditive deficits not allowing the realization of the test
- Evolutive disease (such as cancer)
- Neurological or psychiatric antecedent
- Counter-indication to MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Localized Analysis of Normalized Distance From Scalp to Cortex and Personalized Evaluation (LANDSCAPE): A Project of MRI-informed Computational Head Model
Scalp to cortex distance (SCD), as a key technological parameter of brain stimulation, has been highlighted in the guidelines of non-invasive brain stimulation. However, in the context of age-related brain changes, the region-specific SCD and its impact on stimulation-induced electric field in different types of neurodegenerative diseases remain unclear.
Read the detailed description
Objective: This study aimed to investigate the region-specific SCD and its relationship with morphometric features and cognitive function in age- and disease-specific populations. Methods: The SCD and cortical thickness (CT) of left primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC) were measured in cognitively normal adults and dementia patients. CT-adjusted SCD was used to control the influence of CT on SCD. Head model was developed to simulate the impact of SCD on the electric field induced by transcranial electrical stimulation.
- Conditions
- Aging, Dementia Alzheimers, Parkinson Disease, Dementia Frontotemporal, Depression in Old Age
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- Aging, Scalp-to-cortex distance, Transcranial brain stimulation, Parkinson disease, Simulation, Predictor
- Medical subject headings
- Alzheimer Disease, Parkinson Disease, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
One time for each day, lasting for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Neurocognitive disorder (NCD) | The NCD patients are defined with a chronological age over 60 years and a Montreal Cognitive Assessment (MoCA) total score between 22 and 26. Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scalp-to-cortex distance will be measured using geometric brain model
Scalp-to-cortex distance (SCD), as a geometric feature, will measured in the Brainsight TMS neuronavigation system.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start15 Jun 2023
- Primary completion14 Dec 2024
- Study completion14 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 488 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LU Hanna, Chinese University of Hong Kong
- Investigators
- Hanna LU, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967390
- Sponsor's protocol ID
- 2018.077
- Other IDs
- 2018.077
- Status last verified
- Jan 2025
- First submitted
- 15 Jun 2023
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localized Analysis of Normalized Distance From Scalp to Cortex and Personalized Evaluation (LANDSCAPE): A Project of MRI-informed Computational Head Model
- ClinicalTrials.gov ID
- NCT05967390
- Acronym / sponsor ID
- 2018.077
- Conditions
- Aging, Dementia Alzheimers, Parkinson Disease, Dementia Frontotemporal, Depression in Old Age
- Keywords
- Aging, Scalp-to-cortex distance, Transcranial brain stimulation, Parkinson disease, Simulation, Predictor
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 488 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 14 Dec 2024 (actual)
- Study completion
- 14 Jun 2025 (estimated)
- First posted
- 1 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.
Scalp to cortex distance (SCD), as a key technological parameter of brain stimulation, has been highlighted in the guidelines of non-invasive brain stimulation. However, in the context of age-related brain changes, the region-specific SCD and its impact on stimulation-induced electric field in different types of neurodegenerative diseases remain unclear.
Detailed description
Objective: This study aimed to investigate the region-specific SCD and its relationship with morphometric features and cognitive function in age- and disease-specific populations. Methods: The SCD and cortical thickness (CT) of left primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC) were measured in cognitively normal adults and dementia patients. CT-adjusted SCD was used to control the influence of CT on SCD. Head model was developed to simulate the impact of SCD on the electric field induced by transcranial electrical stimulation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurocognitive disorder (NCD) | – | Device: Transcranial Magnetic StimulationThe NCD patients are defined with a chronological age over 60 years and a Montreal Cognitive Assessment (MoCA) total score between 22 and 26. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy normal ageing adults and adults with neurocognitive disorders
Key inclusion criteria (4 listed)
- Right-handed as assessed by the Edinburgh Inventory
- Able to attend TMS interventions
- Consent
- Independent in daily life activities
Key exclusion criteria (4 listed)
- Uncorrected visual or auditive deficits not allowing the realization of the test
- Evolutive disease (such as cancer)
- Neurological or psychiatric antecedent
- Counter-indication to MRI
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 Magnetic StimulationOne time for each day, lasting for three weeks. | Device | Neurocognitive disorder (NCD) |
Primary outcome
Scalp-to-cortex distance will be measured using geometric brain model
Time frame: Baseline
Scalp-to-cortex distance (SCD), as a geometric feature, will measured in the Brainsight TMS neuronavigation system.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Hanna LU, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Dementia Alzheimers, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 4 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: enrolling by invitation, as of the sponsor's last update on 14 Jan 2025. 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 Hong Kong. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scalp-to-cortex distance will be measured using geometric brain model (time frame: Baseline). 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 14 Jan 2025; AzTrials last refreshed its copy on 31 Oct 2026.