Localized Analysis of Normalized Distance From Scalp to Cortex and Personalized Evaluation (LANDSCAPE)

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT05967390

Collaborator

(none)

488

Enrollment

Location

Anticipated Duration (Months)

20.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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 neurodegenerative diseases remain unclear.

Condition or Disease	Intervention/Treatment	Phase
Aging Dementia Alzheimers Parkinson Disease Dementia Frontotemporal Depression in Old Age	Device: Transcranial Magnetic Stimulation

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

Study Type:

Observational

Anticipated Enrollment :

488 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Localized Analysis of Normalized Distance From Scalp to Cortex and Personalized Evaluation (LANDSCAPE): A Project of MRI-informed Computational Head Model

Actual Study Start Date :

Jun 15, 2023

Anticipated Primary Completion Date :

Jun 14, 2024

Anticipated Study Completion Date :

Jun 14, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Transcranial Magnetic Stimulation One time for each day, lasting for three weeks.

Arm

Intervention/Treatment

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.

Device: Transcranial Magnetic Stimulation

One time for each day, lasting for three weeks.

Outcome Measures

Primary Outcome Measures

Scalp-to-cortex distance will be measured using geometric brain model [Baseline]
Scalp-to-cortex distance (SCD), as a geometric feature, will measured in the Brainsight TMS neuronavigation system.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Right-handed as assessed by the Edinburgh Inventory
Able to attend TMS interventions
Consent
Independent in daily life activities

Exclusion Criteria:

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