Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis

University Hospital of Mont-Godinne100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

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

Interventions

tDCSDEVICE

Device: transcranial direct current stimulation tDCS tdcs (ELDITH, Neuroconn, Ilmenau, Germany)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Neurology, CHU Dinant Godinne UcL Namur

Yvoir, Namur, Belgium

Outcomes

Primary Outcomes

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.

Time frame: from baseline to 4 weeks after the intervention

Secondary Outcomes

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.

Time frame: 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.

Time frame: from baseline to 4 weeks after the intervention

Data from ClinicalTrials.gov

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