Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis

NCT ID: NCT02266121

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2023-05-08

Brief Summary

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

Detailed Description

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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.

Conditions

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Relapsing Remitting Multiple Sclerosis Secondary-progressive Multiple Sclerosis Cognitive Deficits Motor Deficits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type DEVICE

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

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)

Group Type PLACEBO_COMPARATOR

tDCS

Intervention Type DEVICE

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

Interventions

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tDCS

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université Catholique de Louvain

OTHER

Sponsor Role collaborator

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role collaborator

University Hospital of Mont-Godinne

OTHER

Sponsor Role lead

Responsible Party

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Pr Yves Vandermeeren, MD, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Neurology, CHU Dinant Godinne UcL Namur

Yvoir, Namur, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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B039201421534

Identifier Type: -

Identifier Source: org_study_id

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