Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02266121
• Other study ID #: B039201421534
• Status: Terminated
• Phase: N/A
• Start date: October 2014
• Est. completion date: May 8, 2023

Study information

• Verified date: May 2023
• Source: University Hospital of Mont-Godinne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: May 8, 2023
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Deficits
• Cognitive Dysfunction
• Motor Deficits
• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis
• Secondary-progressive Multiple Sclerosis

Intervention

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

Locations

Country	Name	City	State
Belgium	Department of Neurology, CHU Dinant Godinne UcL Namur	Yvoir	Namur

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital of Mont-Godinne	Teva Pharmaceuticals USA, Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from baseline to 4 weeks after the intervention
Secondary	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.	from baseline to 4 weeks after the intervention
Secondary	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.	from baseline to 4 weeks after the intervention