Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis (MScog-tDCS)

University Hospital of Mont-Godinne

Status: Terminated

Conditions: Secondary-progressive Multiple Sclerosis; Motor Deficits; Cognitive Deficits; Relapsing Remitting Multiple Sclerosis

Treatments: Device: tDCS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02266121

B039201421534

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

real tDCS

Active Comparator group

Description:

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

Treatment:

Device: tDCS

Sham tDCS

Placebo Comparator group

Description:

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)

Treatment:

Device: tDCS