MScog-tDCS: Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis

Sponsor

University Hospital of Mont-Godinne (Other)

Overall Status

Suspended

CT.gov ID

NCT02266121

Collaborator

Université Catholique de Louvain (Other), Teva Pharmaceuticals USA (Industry)

100

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Relapsing Remitting Multiple Sclerosis Secondary-progressive Multiple Sclerosis Cognitive Deficits Motor Deficits	Device: tDCS	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: real tDCS 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 Device: transcranial direct current stimulation tDCS tdcs (ELDITH, Neuroconn, Ilmenau, Germany)
Placebo Comparator: Sham tDCS 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 Device: transcranial direct current stimulation tDCS tdcs (ELDITH, Neuroconn, Ilmenau, Germany)

Arm

Intervention/Treatment

Active Comparator: real tDCS

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

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

Placebo Comparator: Sham tDCS

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

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

Outcome Measures

Primary Outcome Measures

Enhancement of Cognitive aptitudes with tDCS [from baseline to 4 weeks after the intervention]
The effect of intervention on attentional, working memory and executive function deficits will be quantified by means of validated tests before and after intervention.

Secondary Outcome Measures

Enhancement of Motor skills with tDCS [from baseline to 4 weeks after the intervention]
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.
Impact on Fatigue and Enhancement of Cognitive performances with tDCS [from baseline to 4 weeks after the intervention]
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.