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

NCT ID: NCT05962281

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-07-31

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 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.

Conditions

Multiple Sclerosis; Neurophysiologic Abnormality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: QUADRUPLE

Study Groups

Individualized tDCS

Each participant will be screened according to their brain scan, they will receive individualized dose of tDCS currents.

Group Type: ACTIVE_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

Transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation which involves the use of low intensity currents propagated via the scalp, is widely implemented as both a fundamental and clinical neuroscientific tool. Over the last decades, tDCS showed significant therapeutic promise, as numerous studies revealed that it can result in improved attention and executive functions in patients with neurological disorders, through modification of neuronal excitability.

Fixed currents tDCS

All of the participant will receive standardized dose of tDCS currents intensity of 2 mA.

Group Type: ACTIVE_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

Transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation which involves the use of low intensity currents propagated via the scalp, is widely implemented as both a fundamental and clinical neuroscientific tool. Over the last decades, tDCS showed significant therapeutic promise, as numerous studies revealed that it can result in improved attention and executive functions in patients with neurological disorders, through modification of neuronal excitability.

Sham tDCS

The electrodes will applied to the cortical areas, however none of all of the participant will receive the current dose of tDCS.

Group Type: SHAM_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

Transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation which involves the use of low intensity currents propagated via the scalp, is widely implemented as both a fundamental and clinical neuroscientific tool. Over the last decades, tDCS showed significant therapeutic promise, as numerous studies revealed that it can result in improved attention and executive functions in patients with neurological disorders, through modification of neuronal excitability.

Interventions

Transcranial direct current stimulation (tDCS)

Transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation which involves the use of low intensity currents propagated via the scalp, is widely implemented as both a fundamental and clinical neuroscientific tool. Over the last decades, tDCS showed significant therapeutic promise, as numerous studies revealed that it can result in improved attention and executive functions in patients with neurological disorders, through modification of neuronal excitability.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Right-handed volunteers, assessed by Edinburgh handedness inventory
• Normal or corrected-to-normal vision
• Greater than or equal to 18 years old
• Relapsing-remitting type of MS (RRMS)
• Moderate disability EDSS score ≤ 6.5
• Free of relapsing attack at least a month before recruitment

Exclusion Criteria

• Subject recently had a seizure or epilepsy
• Subject is a habitual smoker;
• Subject has a history of any major disease that may interfere with the investigations (especially liver and kidney disease, upper limb pathologies, history of significant multiple traumas, or diabetes) or cancer;
• Subject has any history of a major neurological disorder in addition to MS (including previous severe brain trauma and cognitive impairment) or known cerebral structural abnormalities;
• Subject has a diagnosed mental disorder (e.g., depression, bipolar disorder, schizophrenia, psychoses);
• Subject is currently a user (including ''recreational use'') of any illicit drugs or has a history of drug or alcohol abuse;
• Subject has significant abnormalities on T1/T2 MRI scan;
• Subject has a contra-indication for MRI scanning or TMS measurements (see screening forms for MRI and TMS);
• Subject does not understand the study procedure;
• Subject is unwilling or unable to perform all study procedures, or is considered unsuitable in any way by the principal investigator;
• Subject is not able to perform the motor tasks;
• Subject is (potentially) pregnant (in case of doubt, hCG test will be conducted in female participants); subject is breastfeeding at the time of the study;
• Subject chronically uses medication, especially sedatives or sleep medication (contraceptives allowed). Other medication that is only taken as needed will be allowed at the investigator's discretion;
• Using TMS, no (sufficiently stable) MEPs can be evoked at left M1;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BOF-BILA

UNKNOWN

Sponsor Role: collaborator

Koen Cuypers

OTHER

Sponsor Role: lead

Responsible Party

Koen Cuypers

Assoc. Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Koen Cuypers, PhD

Role: PRINCIPAL_INVESTIGATOR

UHasselt

Central Contacts

Hussein Youssef, MSc

Role: CONTACT

youssef.hussein@uhasselt.be

+32488332512

Other Identifiers

BOF23DOCBL02

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

B1152023000005

Identifier Type: -

Identifier Source: org_study_id