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Clinical Trials/NCT02266121
NCT02266121
Terminated
Not Applicable

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

University Hospital of Mont-Godinne1 site in 1 country100 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Relapsing Remitting Multiple Sclerosis
Sponsor
University Hospital of Mont-Godinne
Enrollment
100
Locations
1
Primary Endpoint
Enhancement of Cognitive aptitudes with tDCS
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
May 8, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
University Hospital of Mont-Godinne
Responsible Party
Principal Investigator
Principal Investigator

Pr Yves Vandermeeren, MD, PhD

Professor

University Hospital of Mont-Godinne

Eligibility Criteria

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

Outcomes

Primary Outcomes

Enhancement of Cognitive aptitudes with tDCS

Time Frame: 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 Outcomes

  • Enhancement of Motor skills with tDCS(from baseline to 4 weeks after the intervention)
  • Impact on Fatigue and Enhancement of Cognitive performances with tDCS(from baseline to 4 weeks after the intervention)

Study Sites (1)

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