NCT02266121

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2014

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

8.6 years

First QC Date

October 10, 2014

Last Update Submit

May 8, 2023

Conditions

Relapsing Remitting Multiple SclerosisSecondary-progressive Multiple SclerosisCognitive DeficitsMotor Deficits

Keywords

Multiple SclerosisMSCognitive deficitsMotor deficitsFatigueNervous System DiseasesBrain DiseasesBrain stimulationWorking memoryMotor learningCentral Nervous System DiseasesNeuropsychological rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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 Arms (2)

real tDCS

ACTIVE COMPARATOR

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

Sham tDCS

PLACEBO COMPARATOR

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

Interventions

tDCSDEVICE

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

Sham tDCSreal tDCS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MS patients with relapsing remitting MS/secondary progression MS (based on the 2010 revised McDonald criteria)
  • Cognitive deficits
  • Motor deficits

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, CHU Dinant Godinne UcL Namur

Yvoir, Namur, B-5530, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis, Chronic ProgressiveCognition DisordersNeurologic ManifestationsMultiple SclerosisFatigueNervous System DiseasesBrain DiseasesCentral Nervous System Diseases

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersSigns and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 10, 2014

First Posted

October 16, 2014

Study Start

October 1, 2014

Primary Completion

May 8, 2023

Study Completion

May 8, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations

BE(1)