Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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;

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05962281
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Koen Cuypers
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Koen Cuypers, PhD
Principal Investigator Affiliation	UHasselt
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis, Neurophysiologic Abnormality

Arms & Interventions

Arms

Active Comparator: Individualized tDCS

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

Active Comparator: Fixed currents tDCS

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

Sham Comparator: Sham tDCS

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

Interventions

Device: - 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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Hussein Youssef, MSc

[email protected]

+32488332512

For additional contact information, you can also visit the trial on clinicaltrials.gov.

Clinical Trials in MS

The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Clinical Trial Finder