Cognitive Improvement Through tDCS for Patients With Multiple Sclerosis
MS-CICS
1 other identifier
interventional
30
1 country
1
Brief Summary
Multiple sclerosis (MS) is a chronic inflammatory disease with around 200.000 patients in Germany. Besides physical symptoms, cognitive resources degrade over the years. Transcranial direct current stimulation (tDCS) is an established procedure to modulate cortical excitability in motor and cognitive functions. Therefore, tDCS may improve cognitive functions in patients with MS. Patients will work on a modified version of the symbol digits modalities test in two experimental sessions. During the task, they will receive either active stimulation or sham stimulation in a crossover design. Active stimulation is divided in anodal and cathodal stimulation. Anodal stimulation should facilitate cognitive processing; cathodal stimulation, on the other hand, should hinder cognitive processing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-sclerosis
Started Dec 2020
Typical duration for not_applicable multiple-sclerosis
1 active site
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
First Submitted
Initial submission to the registry
December 8, 2020
CompletedStudy Start
First participant enrolled
December 8, 2020
CompletedFirst Posted
Study publicly available on registry
December 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMay 15, 2023
May 1, 2023
3.1 years
December 8, 2020
May 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Reaction Times in symbol-digit modalities test.
Reaction times in milliseconds for the performance of the symbol-digit modalities test.
Assessed at two timepoints (1x during active (anodal/cathodal) tDCS intervention at Day 1 or 7 (depends on randomization), 1x during sham tDCS intervention at Day 1 or 7 (depends on randomization))
Secondary Outcomes (2)
Hit Rate in symbol-digit modalities test.
Assessed at two timepoints (1x during active (anodal/cathodal) tDCS intervention at Day 1 or 7 (depends on randomization), 1x during sham tDCS intervention at Day 1 or 7 (depends on randomization))
Baseline performance in symbol-digit modalities test.
Assessment at baseline (Day 0, before stimulation).
Study Arms (4)
Anodal transcranial direct current stimulation
EXPERIMENTALPatients will be bilaterally stimulated with anodal tDCS at the parietal cortex (Brodmann Area 7).
Cathodal transcranial direct current stimulation
EXPERIMENTALPatients will be bilaterally stimulated with cathodal tDCS at the parietal cortex (Brodmann Area 7).
Sham transcranial direct current stimulation for anodal group
SHAM COMPARATORPatients will be bilaterally stimulated with sham tDCS at the parietal cortex (Brodmann Area 7). As a consequence of the crossover design, both experimental arms receive sham stimulation.
Sham transcranial direct current stimulation for cathodal group
SHAM COMPARATORPatients will be bilaterally stimulated with sham tDCS at the parietal cortex (Brodmann Area 7). As a consequence of the crossover design, both experimental arms receive sham stimulation.
Interventions
A high-definition tDCS set-up will be used with a battery-driven stimulator (Starstim 8, Neuroelectrics). Active stimulation will be conducted with 1.5 milliampere (mA) with two electrodes using three reference electrodes for each active one for 20 minutes.
A high-definition tDCS set-up will be used with a battery-driven stimulator (Starstim 8, Neuroelectrics). Sham stimulation will have a 40 seconds ramp-up and down. No stimulation will be applied after this 40 seconds.
Eligibility Criteria
You may qualify if:
- diagnosis of multiple sclerosis.
- no acute inflammation during the last 3 months before the experimental intervention.
- no cortisol treatment during the last 3 months before the experimental intervention.
- stable medication during the experimental intervention.
- unrestrained or corrected visual ability.
- ability to read and write short german sentences.
- adequate motor ability to give responses on a keyboard.
- German as main language.
You may not qualify if:
- major depressive symptoms or any further neurological and/or psychiatric disease at experimental intervention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medicine Greifswald
Greifswald, 17489, Germany
Related Publications (1)
Riemann S, Mittelstadt M, Glatzki M, Zilges C, Wolff C, Niemann F, Roheger M, Floel A, Grothe M, Meinzer M. Information processing speed modulation by electrical brain stimulation in multiple sclerosis: towards individually tailored protocols. Brain Commun. 2025 Jun 6;7(3):fcaf223. doi: 10.1093/braincomms/fcaf223. eCollection 2025.
PMID: 40574976DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcus Meinzer, Prof., PhD
Universitymedicine Greifswald
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participants and investigators are blinded according to the sham / active stimulation.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2020
First Posted
December 14, 2020
Study Start
December 8, 2020
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
May 15, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share