Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis

Not Applicable

Terminated

• Conditions: Secondary-progressive Multiple Sclerosis; Motor Deficits; Cognitive Deficits; Relapsing Remitting Multiple Sclerosis
• Interventions: Device: tDCS

• Registration Number: NCT02266121
• Lead Sponsor: University Hospital of Mont-Godinne

Brief Summary

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

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-10-10
• Study First Posted: 2014-10-16
• Status Verified: 2023-05
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-08
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham tDCS	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)
real tDCS	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Neurology, CHU Dinant Godinne UcL Namur; 🇧🇪 Yvoir, Namur, Belgium