Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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Noninvasive brain stimulations (NIBS) will be used in MS patients with cognitive impairments to enhance their cognitive aptitudes.

Detailed Description
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tDCS will be used in a sham-controlled, double-blind, randomized, cross-over control trial in MS patients suffering from cognitive impairments and/or motor deficits. After informed consent and recruitment, patients will be randomly (computer method) allocated to real or sham tDCS, that will be applied during working memory and attentional tasks. A few days/weeks after completing one arm, the patients will enter the other arm (double-blind cross-over design). Baseline and follow-up outcomes about cognitive aptitudes, motor tasks and fatigue will be collected.

Official Title
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Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis / Améliorer Les capacités Cognitives Par tDCS Chez Les Patients Souffrants de sclérose en Plaques

Conditions
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Relapsing Remitting Multiple Sclerosis, Secondary-progressive Multiple Sclerosis, Cognitive Deficits, Motor Deficits

Intervention / Treatment
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* Device: tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MS patients with relapsing remitting MS/secondary progression MS (based on the 2010 revised McDonald criteria) Cognitive deficits Motor deficits Exclusion Criteria: contraindication to tDCS (seizure or epilepsy, metal in the head, …) major psychiatric conditions or major depression coexisting instable medical condition substance or alcohol abuse regular intake of drug that strongly modulate brain excitability major sequels from MS preventing participation in the study pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: real tDCS<br>Patients will receive non-invasive and painless brain stimulation over the rain areas involved in cognitive aptitudes. tDCS will be applied during 20 minutes while patients will perform attentional, working memory and executive tasks | Device: tDCS<br>* Device: transcranial direct current stimulation tDCS tdcs (ELDITH, Neuroconn, Ilmenau, Germany)<br>|
| Placebo Comparator: Sham tDCS<br>this will be exactly as for real tDCS unless that the tDCS will be rapidly turned off, unbeknown from patients-therapist-examinator (double-blind trial) | Device: tDCS<br>* Device: transcranial direct current stimulation tDCS tdcs (ELDITH, Neuroconn, Ilmenau, Germany)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enhancement of Cognitive aptitudes with tDCS | The effect of intervention on attentional, working memory and executive function deficits will be quantified by means of validated tests before and after intervention. | from baseline to 4 weeks after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enhancement of Motor skills with tDCS | Performance on motor skill learning tasks and on different commonly used tasks (Purdue Pegboard, hand dynamometer, pinch dynamometer, 9-HPT, motor skill learning with a videogame, ...) will be measured to explore the impact of tDCS on these parameters in MS patients' population. | from baseline to 4 weeks after the intervention | 
| Impact on Fatigue and Enhancement of Cognitive performances with tDCS | The effect of intervention on fatigue and performances on the cognitive tasks will be quantified by means of validated questionnaires at inclusion and after tDCS. | from baseline to 4 weeks after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motor learning, Multiple Sclerosis, MS, Cognitive deficits, Motor deficits, Fatigue, Nervous System Diseases, Brain Diseases, Brain stimulation, Working memory, Central Nervous System Diseases, Neuropsychological rehabilitation