Viewing Study NCT05962281



Ignite Creation Date: 2024-05-06 @ 7:18 PM
Last Modification Date: 2024-10-26 @ 3:04 PM
Study NCT ID: NCT05962281
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-07-27
First Post: 2023-06-02

Brief Title: Investigation The Effect of Conventional Vs Individualized tDCS Intensity to Achieve Uniform E-Fields
Sponsor: Koen Cuypers
Organization: Hasselt University

Study Overview

Official Title: Investigation The Effect of Conventional Vs Individualized Transcranial Direct Current Stimulation Intensity to Achieve Uniform E-Fields
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Background Replications of studies employing transcranial direct stimulation tDCS shows great variations in physiological and behavioral outcomes The disparity between studies is based on the expectations of getting the same cortical activity changes consistently once the procedures and current parameters have been repeated Nevertheless this assumption was inoperative due to the individualized variations of numerous parameters such as age disease type symptom severity head geometry etc

Objective Through this clinical trial we aim to reduce the variability of the physiological and behavioral outcomes of tDCS by individualizing the current intensity and to study the neurophysiological and behavioral outcome differences between participants who receive the customized current intensity in comparison to the others who would receive a fixed dose

Methods Based on individual patients structural MRI images the Electrical field E-field distribution can be modeled and the individualized current dose to stimulate a target region can be determined A group of thirty persons with multiple sclerosis PWMS would be pseudo-randomized into three groups receiving all 3 treatments of individualized tDCS fixed currents 2 mA and sham tDCS Baseline and post-intervention assessment of physiological and behavioral outcome measures will be assessed using respectively transcranial magnetic stimulation TMS recruitment curve and a stop-signal task and GONo-go test

Significant statement and clinical relevance Individualizing the patients tDCS current intensity will result in a better clinical outcome ie more robust physiological and behavioral effects as compared to a tDCS application that is based on a fixed current
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
BOF23DOCBL02 OTHER_GRANT Special Research Fund BOF None