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

NCT05967390 | Enrolling By Invitation FDA Device

• 1 other identifier: 2018.077
• Study Type: observational
• Target: 488
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Transcranial Magnetic Stimulation DEVICE

One time for each day, lasting for three weeks.

Neurocognitive disorder (NCD)

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy normal ageing adults and adults with neurocognitive disorders

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Tai Po Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Alzheimer Disease; Parkinson Disease; Pick Disease of the Brain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Frontotemporal Dementia; Frontotemporal Lobar Degeneration

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Hanna LU, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: August 1, 2023
• Study Start: June 15, 2023
• Primary Completion: December 14, 2024
• Study Completion: June 14, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Locations

HK (1)