Back to resultsImproving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis (MScog-tDCS)
Primary Purpose
Relapsing Remitting Multiple Sclerosis, Secondary-progressive Multiple Sclerosis, Cognitive Deficits
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Multiple Sclerosis, MS, Cognitive deficits, Motor deficits, Fatigue, Nervous System Diseases, Brain Diseases, Brain stimulation, Working memory, Motor learning, Central Nervous System Diseases, Neuropsychological rehabilitation
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
Sites / Locations
- Department of Neurology, CHU Dinant Godinne UcL Namur
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
real tDCS
Sham tDCS
Arm 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
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)
Outcomes
Primary Outcome Measures
Enhancement of Cognitive aptitudes with tDCS
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
Enhancement of Motor skills with tDCS
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
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.
Full Information
NCT ID
NCT02266121
First Posted
October 10, 2014
Last Updated
May 8, 2023
Sponsor
University Hospital of Mont-Godinne
Collaborators
Université Catholique de Louvain, Teva Pharmaceuticals USA
1. Study Identification
Unique Protocol Identification Number
NCT02266121
Brief Title
Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis
Acronym
MScog-tDCS
Official Title
Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis / Améliorer Les capacités Cognitives Par tDCS Chez Les Patients Souffrants de sclérose en Plaques
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitement
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 8, 2023 (Actual)
Study Completion Date
May 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Mont-Godinne
Collaborators
Université Catholique de Louvain, Teva Pharmaceuticals USA
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis, Secondary-progressive Multiple Sclerosis, Cognitive Deficits, Motor Deficits
Keywords
Multiple Sclerosis, MS, Cognitive deficits, Motor deficits, Fatigue, Nervous System Diseases, Brain Diseases, Brain stimulation, Working memory, Motor learning, Central Nervous System Diseases, Neuropsychological rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
real tDCS
Arm Type
Active Comparator
Arm 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
Arm Title
Sham tDCS
Arm Type
Placebo Comparator
Arm 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)
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
Device: transcranial direct current stimulation tDCS tdcs (ELDITH, Neuroconn, Ilmenau, Germany)
Primary Outcome Measure Information:
Title
Enhancement of Cognitive aptitudes with tDCS
Description
The effect of intervention on attentional, working memory and executive function deficits will be quantified by means of validated tests before and after intervention.
Time Frame
from baseline to 4 weeks after the intervention
Secondary Outcome Measure Information:
Title
Enhancement of Motor skills with tDCS
Description
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.
Time Frame
from baseline to 4 weeks after the intervention
Title
Impact on Fatigue and Enhancement of Cognitive performances with tDCS
Description
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.
Time Frame
from baseline to 4 weeks after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Department of Neurology, CHU Dinant Godinne UcL Namur
City
Yvoir
State/Province
Namur
ZIP/Postal Code
B-5530
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis
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