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

• Conditions: Dementia Alzheimers; Depression in Old Age; Dementia Frontotemporal; Aging; Parkinson Disease
• Interventions: Device: Transcranial Magnetic Stimulation

• Registration Number: NCT05967390
• Lead Sponsor: Chinese University of Hong Kong

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.

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 Timeline

• Study Start: 2023-06-15
• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2024-12-14
• Study Completion: 2025-06-14

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 488

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neurocognitive disorder (NCD)	Transcranial Magnetic Stimulation	The NCD patients are defined with a chronological age over 60 years and a Montreal Cognitive Assessment (MoCA) total score between 22 and 26.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tai Po Hospital; 🇭🇰 Hong Kong, Hong Kong