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

May 8, 2023 updated by: Pr Yves Vandermeeren, MD, PhD, University Hospital of Mont-Godinne

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Namur
      • Yvoir, Namur, Belgium, B-5530
        • Department of Neurology, CHU Dinant Godinne UcL Namur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from baseline to 4 weeks after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enhancement of Motor skills with tDCS
Time Frame: 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.
from baseline to 4 weeks after the intervention
Impact on Fatigue and Enhancement of Cognitive performances with tDCS
Time Frame: 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.
from baseline to 4 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Mont-Godinne

Collaborators

Université Catholique de Louvain
Teva Pharmaceuticals USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

May 8, 2023

Study Completion (Actual)

May 8, 2023

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

October 10, 2014

First Posted (Estimate)

October 16, 2014

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B039201421534

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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