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

Primary Purpose

Multiple Sclerosis, Neurophysiologic Abnormality

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS)
Sponsored by
Koen Cuypers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Brain Stimulation, Non-invasive Brain Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Sham Comparator

    Arm Label

    Individualized tDCS

    Fixed currents tDCS

    Sham tDCS

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    Transcranial Magnetic Stimulation (TMS) Assessment
    Changes in cortical excitability will be measured by single and paired TMS pulses. The final values will be assessed for improvements.

    Secondary Outcome Measures

    Behavioral Assessment
    A cognitive test battery consisting of: 1- Symbol Digit Modality Test (SDMT); the final score is the correct number of substitutions in 90 seconds, and scores range between 0 and 110, where higher scores indicating better outcome, and the lower scores indicating worse outcome.

    Full Information

    First Posted
    June 2, 2023
    Last Updated
    July 24, 2023
    Sponsor
    Koen Cuypers
    Collaborators
    BOF-BILA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05962281
    Brief Title
    Investigation The Effect of Conventional Vs. Individualized tDCS Intensity to Achieve Uniform E-Fields
    Official Title
    Investigation The Effect of Conventional Vs. Individualized Transcranial Direct Current Stimulation Intensity to Achieve Uniform E-Fields
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2024 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    July 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Koen Cuypers
    Collaborators
    BOF-BILA

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis, Neurophysiologic Abnormality
    Keywords
    Multiple Sclerosis, Brain Stimulation, Non-invasive Brain Stimulation

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Individualized tDCS
    Arm Type
    Active Comparator
    Arm Description
    Each participant will be screened according to their brain scan, they will receive individualized dose of tDCS currents.
    Arm Title
    Fixed currents tDCS
    Arm Type
    Active Comparator
    Arm Description
    All of the participant will receive standardized dose of tDCS currents intensity of 2 mA.
    Arm Title
    Sham tDCS
    Arm Type
    Sham Comparator
    Arm Description
    The electrodes will applied to the cortical areas, however none of all of the participant will receive the current dose of tDCS.
    Intervention Type
    Device
    Intervention Name(s)
    Transcranial direct current stimulation (tDCS)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Transcranial Magnetic Stimulation (TMS) Assessment
    Description
    Changes in cortical excitability will be measured by single and paired TMS pulses. The final values will be assessed for improvements.
    Time Frame
    Baseline assessment before tDCS session (Pre-intervention), and immediately following tDCS session (Post-intervention).
    Secondary Outcome Measure Information:
    Title
    Behavioral Assessment
    Description
    A cognitive test battery consisting of: 1- Symbol Digit Modality Test (SDMT); the final score is the correct number of substitutions in 90 seconds, and scores range between 0 and 110, where higher scores indicating better outcome, and the lower scores indicating worse outcome.
    Time Frame
    Baseline assessment before tDCS session (Pre-intervention), and immediately following tDCS session (Post-intervention).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hussein Youssef, MSc
    Phone
    +32488332512
    Email
    youssef.hussein@uhasselt.be
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Koen Cuypers, PhD
    Organizational Affiliation
    UHasselt
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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