Multiple SclerosisNCT05962281
Investigation The Effect of Conventional Vs. Individualized tDCS Intensity to Achieve Uniform E-Fields
A study testing Transcranial direct current stimulation (tDCS) in people with Multiple Sclerosis and Neurophysiologic Abnormality, run by Koen Cuypers.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Neurophysiologic Abnormality
- What is being tested?
- Transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation The Effect of Conventional Vs. Individualized Transcranial Direct Current Stimulation Intensity to Achieve Uniform E-Fields
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.
Read more
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
- Being tested
- Transcranial direct current stimulation (tDCS)
- Keywords
- Multiple Sclerosis, Brain Stimulation, Non-invasive Brain Stimulation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)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.
| Study group | Role | What they receive |
|---|---|---|
| Individualized tDCS | Active comparator | Each participant will be screened according to their brain scan, they will receive individualized dose of tDCS currents. Receives: Device: Transcranial direct current stimulation (tDCS) |
| Fixed currents tDCS | Active comparator | All of the participant will receive standardized dose of tDCS currents intensity of 2 mA. Receives: Device: Transcranial direct current stimulation (tDCS) |
| Sham tDCS | Sham comparator | The electrodes will applied to the cortical areas, however none of all of the participant will receive the current dose of tDCS. Receives: Device: Transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline assessment before tDCS session (Pre-intervention), and immediately following tDCS session (Post-intervention).
Secondary outcomes (1)
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.
Measured: Baseline assessment before tDCS session (Pre-intervention), and immediately following tDCS session (Post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Mar 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koen Cuypers
- Sponsor type
- University, hospital or other
- Collaborators
- BOF-BILA
- Responsible party
- Sponsor-investigator, Koen Cuypers, Hasselt University
- Investigators
- Koen Cuypers, PhD, Principal investigator, UHasselt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962281
- Sponsor's protocol ID
- B1152023000005
- Other IDs
- BOF23DOCBL02
- Status last verified
- Jul 2023
- First submitted
- 2 Jun 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation The Effect of Conventional Vs. Individualized Transcranial Direct Current Stimulation Intensity to Achieve Uniform E-Fields
- ClinicalTrials.gov ID
- NCT05962281
- Acronym / sponsor ID
- B1152023000005
- Conditions
- Multiple Sclerosis, Neurophysiologic Abnormality
- Keywords
- Multiple Sclerosis, Brain Stimulation, Non-invasive Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Koen CuypersUniversity, hospital or other
- Collaborators
- BOF-BILA
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individualized tDCS | Active comparator | Device: Transcranial direct current stimulation (tDCS)Each participant will be screened according to their brain scan, they will receive individualized dose of tDCS currents. |
| Fixed currents tDCS | Active comparator | Device: Transcranial direct current stimulation (tDCS)All of the participant will receive standardized dose of tDCS currents intensity of 2 mA. |
| Sham tDCS | Sham comparator | Device: Transcranial direct current stimulation (tDCS)The electrodes will applied to the cortical areas, however none of all of the participant will receive the current dose of tDCS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Fixed currents tDCS, Individualized tDCS, Sham tDCS |
Primary outcome
Transcranial Magnetic Stimulation (TMS) Assessment
Time frame: Baseline assessment before tDCS session (Pre-intervention), and immediately following tDCS session (Post-intervention).
Changes in cortical excitability will be measured by single and paired TMS pulses. The final values will be assessed for improvements.
1 secondary outcome
Behavioral Assessment
Time frame: Baseline assessment before tDCS session (Pre-intervention), and immediately following tDCS session (Post-intervention).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koen Cuypers, PhD principal investigator
UHasselt
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS) in people with Multiple Sclerosis and Neurophysiologic Abnormality, run by Koen Cuypers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hussein Youssef, MSc (+32488332512, youssef.hussein@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcranial Magnetic Stimulation (TMS) Assessment (time frame: Baseline assessment before tDCS session (Pre-intervention), and immediately following tDCS session (Post-intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.