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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05967390
• Other study ID #: 2018.077
• Secondary ID: 2018.077
• Status: Recruiting
• Start date: June 15, 2023
• Est. completion date: June 14, 2025

Study information

• Verified date: December 2023
• Source: Chinese University of Hong Kong
• Contact: Hanna LU, PhD
• Phone: 28314305
• Email: hannalu[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical 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 neurodegenerative diseases remain unclear.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 488
• Est. completion date: June 14, 2025
• Est. primary completion date: June 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Alzheimer Disease
• Aphasia, Primary Progressive
• Dementia
• Dementia Alzheimers
• Dementia Frontotemporal
• Depression in Old Age
• Frontotemporal Dementia
• Parkinson Disease
• Pick Disease of the Brain

Intervention

Device:
• Transcranial Magnetic Stimulation
One time for each day, lasting for three weeks.

Locations

Country	Name	City	State
Hong Kong	Tai Po Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline