Multiple SclerosisMS-CICSNCT04667221
Cognitive Improvement Through tDCS for Patients With Multiple Sclerosis
A study testing Active transcranial direct current stimulation in people with Multiple Sclerosis, run by University Medicine Greifswald at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Active transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 8 Dec 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- major depressive symptoms or any further neurological and/or psychiatric disease at experimental intervention.
- standard tDCS exclusion criteria (e.g. cardiac pacemaker, metal implants in head region, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Improvement Through Transcranial Direct Current Stimulation for Patients With Multiple Sclerosis
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.
Read the detailed description
Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease characterized by a multitude of symptoms, which greatly reduce the quality of life of patients. In addition to sensory and visual sensory disorders, movement disorders, paresis, fatigue and other physical symptoms, 65-95% of patients with MS also suffer from cognitive impairments. These cognitive impairments develop in the later course of the disease and express themselves in slower processing speed, delays in learning and memory performance, and executive dysfunction. In recent years, non-pharmacological approaches aimed at improving cognitive performance in MS have increasingly come into focus, including the transcranial direct current stimulation (tDCS).
TDCS has only been investigated in a few studies that had the aim to improve cognitive performance in MS. Further, it has only been carried out in combination with cognitive training paradigms and repeated stimulation sessions. Mattioli and colleagues (2016) could e.g. show that after 10 sessions of cognitive training with tDCS stimulation of the dorsolateral prefrontal cortex, there was greater improvement in symbol-digit modalities test (SDMT) in the experimental group than in the control group. Similarly, Charvet and colleagues (2018) showed that after 10 sessions of cognitive training with simultaneous tDCS stimulation of the dorsolateral prefrontal cortex, the experimental group showed a significant improvement in the domains of attention and response variability compared to the control group. These studies therefore reflect an interaction between cognitive training and tDCS, and do not allow any conclusions to be drawn about the effect of tDCS on specific processes. It is not yet known whether tDCS alone can positively influence specific cognitive functional impairments.
Therefore, the present study wants to investigate whether acute application of tDCS can improve specific cognitive functions. An adapted version of the clinically SDMT was conducted, as this test is one of the most widely used tests to describe cognitive impairments in MS. Based on a meta-analysis by Silva and colleagues (2018), that shows which brain areas are related to the implementation of the SDMT, the parietal cortex (BA7) is stimulated bilaterally with either excitatory (anodal) or inhibitory (cathodal) tDCS.
- Conditions
- Multiple Sclerosis
- Being tested
- Active transcranial direct current stimulation, Sham transcranial direct current stimulation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active transcranial direct current stimulationDevice
Also called non-invasive brain stimulation, transcranial electrical stimulation
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.
Sham transcranial direct current stimulationDevice
Also called non-invasive brain stimulation, transcranial electrical stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| Anodal transcranial direct current stimulation | Experimental | Patients will be bilaterally stimulated with anodal tDCS at the parietal cortex (Brodmann Area 7). Receives: Device: Active transcranial direct current stimulation |
| Cathodal transcranial direct current stimulation | Experimental | Patients will be bilaterally stimulated with cathodal tDCS at the parietal cortex (Brodmann Area 7). Receives: Device: Active transcranial direct current stimulation |
| Sham transcranial direct current stimulation for anodal group | Sham comparator | Patients 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. Receives: Device: Sham transcranial direct current stimulation |
| Sham transcranial direct current stimulation for cathodal group | Sham comparator | Patients 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. Receives: Device: Sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction Times in symbol-digit modalities test.
Reaction times in milliseconds for the performance of the symbol-digit modalities test.
Measured: 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.
Hit rate in percentage of correct responses in the symbol-digit modalities test.
Measured: 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.
Baseline performance of paper-pencil version of the symbol-digit modalities test as a predictor for the stimulation effect.
Measured: Assessment at baseline (Day 0, before stimulation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start8 Dec 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, balanced crossover design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcus Meinzer, Prof., PhD, Principal investigator, Universitymedicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667221
- Sponsor's protocol ID
- MS-CICS
- Acronym
- MS-CICS
- Status last verified
- May 2023
- First submitted
- 8 Dec 2020
- Last updated
- 15 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40574976
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Improvement Through Transcranial Direct Current Stimulation for Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04667221
- Acronym / sponsor ID
- MS-CICS / MS-CICS
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease characterized by a multitude of symptoms, which greatly reduce the quality of life of patients. In addition to sensory and visual sensory disorders, movement disorders, paresis, fatigue and other physical symptoms, 65-95% of patients with MS also suffer from cognitive impairments. These cognitive impairments develop in the later course of the disease and express themselves in slower processing speed, delays in learning and memory performance, and executive dysfunction. In recent years, non-pharmacological approaches aimed at improving cognitive performance in MS have increasingly come into focus, including the transcranial direct current stimulation (tDCS).
TDCS has only been investigated in a few studies that had the aim to improve cognitive performance in MS. Further, it has only been carried out in combination with cognitive training paradigms and repeated stimulation sessions. Mattioli and colleagues (2016) could e.g. show that after 10 sessions of cognitive training with tDCS stimulation of the dorsolateral prefrontal cortex, there was greater improvement in symbol-digit modalities test (SDMT) in the experimental group than in the control group. Similarly, Charvet and colleagues (2018) showed that after 10 sessions of cognitive training with simultaneous tDCS stimulation of the dorsolateral prefrontal cortex, the experimental group showed a significant improvement in the domains of attention and response variability compared to the control group. These studies therefore reflect an interaction between cognitive training and tDCS, and do not allow any conclusions to be drawn about the effect of tDCS on specific processes. It is not yet known whether tDCS alone can positively influence specific cognitive functional impairments.
Therefore, the present study wants to investigate whether acute application of tDCS can improve specific cognitive functions. An adapted version of the clinically SDMT was conducted, as this test is one of the most widely used tests to describe cognitive impairments in MS. Based on a meta-analysis by Silva and colleagues (2018), that shows which brain areas are related to the implementation of the SDMT, the parietal cortex (BA7) is stimulated bilaterally with either excitatory (anodal) or inhibitory (cathodal) tDCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized, balanced crossover design.
| Arm | Type | Receives |
|---|---|---|
| Anodal transcranial direct current stimulation | Experimental | Device: Active transcranial direct current stimulationPatients will be bilaterally stimulated with anodal tDCS at the parietal cortex (Brodmann Area 7). |
| Cathodal transcranial direct current stimulation | Experimental | Device: Active transcranial direct current stimulationPatients will be bilaterally stimulated with cathodal tDCS at the parietal cortex (Brodmann Area 7). |
| Sham transcranial direct current stimulation for anodal group | Sham comparator | Device: Sham transcranial direct current stimulationPatients 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 comparator | Device: Sham transcranial direct current stimulationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- major depressive symptoms or any further neurological and/or psychiatric disease at experimental intervention.
- standard tDCS exclusion criteria (e.g. cardiac pacemaker, metal implants in head region, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active transcranial direct current stimulationAlso: non-invasive brain stimulation, transcranial electrical stimulationA 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. | Device | Anodal transcranial direct current stimulation, Cathodal transcranial direct current stimulation |
| Sham transcranial direct current stimulationAlso: non-invasive brain stimulation, transcranial electrical stimulationA 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. | Device | Sham transcranial direct current stimulation for anodal group, Sham transcranial direct current stimulation for cathodal group |
Primary outcome
Reaction Times in symbol-digit modalities test.
Time frame: 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))
Reaction times in milliseconds for the performance of the symbol-digit modalities test.
2 secondary outcomes
Hit Rate in symbol-digit modalities test.
Time frame: 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.
Time frame: Assessment at baseline (Day 0, before stimulation).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Derived from this study: PubMed 40574976Riemann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Meinzer, Prof., PhD principal investigator
Universitymedicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcranial direct current stimulation in people with Multiple Sclerosis, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction Times in symbol-digit modalities test. (time frame: 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))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04667221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.