Last reviewed · How we verify

NCT05962281

Investigation The Effect of Conventional Vs. Individualized tDCS Intensity to Achieve Uniform E-Fields

Status unknown NA Last updated 27 July 2023
What this trial tests

NA trial testing Transcranial direct current stimulation (tDCS) in Multiple Sclerosis in 30 participants. Status unknown.

Timeline
1 March 2024
Primary endpoint
31 December 2024
31 July 2025

Quick facts

Lead sponsorKoen Cuypers
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposescreening
Enrollment30
Start date1 March 2024
Primary completion31 December 2024
Estimated completion31 July 2025

Drugs / interventions tested

Conditions studied

Sponsor

Koen Cuypers

Who can join

18 and older, any sex, with Multiple Sclerosis or Neurophysiologic Abnormality. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 patient's 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 GO/No-go test. Significant statement and clinical relevance: Individualizing the patient's tDCS current intensity will result in a better clinical outcome (i.e. more robust physiological and behavioral effects), as compared to a tDCS application that is based on a fixed current.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Transcranial direct current stimulation (tDCS)

Trials testing the same drug.

Other recruiting trials for Multiple Sclerosis

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05962281.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing