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| ID | Type | Description | Link |
|---|---|---|---|
| BOF23DOCBL02 | Other Grant/Funding Number | Special Research Fund (BOF) |
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| Name | Class |
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| BOF-BILA | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized tDCS | Active Comparator | Each participant will be screened according to their brain scan, they will receive individualized dose of tDCS currents. |
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| Fixed currents tDCS | Active Comparator | All of the participant will receive standardized dose of tDCS currents intensity of 2 mA. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline assessment before tDCS session (Pre-intervention), and immediately following tDCS session (Post-intervention). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline assessment before tDCS session (Pre-intervention), and immediately following tDCS session (Post-intervention). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hussein Youssef, MSc | Contact | +32488332512 | youssef.hussein@uhasselt.be |
| Name | Affiliation | Role |
|---|---|---|
| Koen Cuypers, PhD | UHasselt | Principal Investigator |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |