Viewing Study NCT06648954



Ignite Creation Date: 2024-10-26 @ 3:43 PM
Last Modification Date: 2024-10-26 @ 3:43 PM
Study NCT ID: NCT06648954
Status: RECRUITING
Last Update Posted: None
First Post: 2024-09-15

Brief Title: Effect of Multisite High-definition Transcranial Direct Current Stimulation Targeting Sensorimotor Network
Sponsor: None
Organization: None

Study Overview

Official Title: Multisite High-definition Transcranial Direct Current Stimulation Targeting Sensorimotor Network Navigated by Task-based fMRI to Facilitate Motor Activation and Reorganization for Stroke
Status: RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Transcranial direct current stimulation tDCS has been applied to facilitate cortical excitability in stroke populations as increasing evidence suggests that clinical recovery from stroke is attributed to neuroplastic reorganization However recovery from stroke following this kind of non-invasive neuromodulation remains divergent across stroke patients due to variations in their etiologies lesion profiles and post-stroke duration

A novel multisite high definition tDCS HD-tDCS in healthy people showed that such network-targeted stimulation could enhance motor excitability beyond conventional stimulation which targeting only one region The electrode placements could be determined by the montage optimization which targets individual motor network activation navigated by task-based fMRI using computation algorithms

By targeting motor network the new multisite electrode montage may provide a potential to facilitate better cortical activation than conventional tDCS montage
Detailed Description: Transcranial direct current stimulation tDCS has been applied to facilitate cortical excitability in stroke populations as increasing evidence suggests that clinical recovery from stroke is attributed to neuroplastic reorganization However recovery from stroke following this kind of non-invasive neuromodulation remains divergent across stroke patients due to variations in their etiologies lesion profiles and post-stroke durations In the stroke application of tDCS most non-invasive brain stimulation studies have mainly focused on the modulation of the primary motor cortex M1 in motor skill relearning Previous studies have shown that not only the M1 which is the most important area associated with the motor system but also other secondary motor areas eg premotor cortex PM and supplementary motor area SMA can be influenced by the onset of stroke In fact SMA activations and shifts in the M1 are commonly observed in stroke patients However brain regions do not operate in isolation but communicate and interact with other discrete regions through networks Conventional stimulations of one region normally the M1 in stroke have neglected the network impact and the changed motor network composition after stroke which is often limited in stroke rehabilitation A novel multisite high definition tDCS HD-tDCS in healthy people showed that such network-targeted stimulation could enhance motor excitability beyond conventional stimulation which targeting only one region It showed that the excitability following multisite HD-tDCS was more than double the increase following conventional tDCS

To consider the various lesion site and the different activation patterns of individual stroke survivors personalized lesion profiles and anatomical features can be determined using finite element modelling with lesion profiles generated from MRI and advanced algorithms calculating the current density to maximize the modulation effect The electrode placements could be determined by the montage optimization which targets individual motor network activation navigated by task-based fMRI using computation algorithms By targeting motor network the new multisite electrode montage may provide a potential to facilitate better cortical activation than conventional tDCS montage

In this study A randomized cross-over designed trial will be conducted to explore motor activation and reorganization changes before and after multisite HD-tDCS conventional tDCS and sham tDCS in stroke survivors The stimulation effect will be evaluated by fMRI

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None