Cognitive Improvement Through tDCS for Patients With Multiple Sclerosis

NCT ID: NCT04667221

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-08
• Study Completion Date: 2023-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Anodal transcranial direct current stimulation

Patients will be bilaterally stimulated with anodal tDCS at the parietal cortex (Brodmann Area 7).

Group Type: EXPERIMENTAL

Active transcranial direct current stimulation

Intervention Type: DEVICE

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.

Cathodal transcranial direct current stimulation

Patients will be bilaterally stimulated with cathodal tDCS at the parietal cortex (Brodmann Area 7).

Group Type: EXPERIMENTAL

Active transcranial direct current stimulation

Intervention Type: DEVICE

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 stimulation for anodal group

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.

Group Type: SHAM_COMPARATOR

Sham transcranial direct current stimulation

Intervention Type: DEVICE

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.

Sham transcranial direct current stimulation for cathodal group

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.

Group Type: SHAM_COMPARATOR

Sham transcranial direct current stimulation

Intervention Type: DEVICE

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.

Interventions

Active transcranial direct current 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.

Intervention Type: DEVICE

Sham transcranial direct current 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.

Intervention Type: DEVICE

Other Intervention Names

non-invasive brain stimulation; transcranial electrical stimulation; non-invasive brain stimulation; transcranial electrical stimulation

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• major depressive symptoms or any further neurological and/or psychiatric disease at experimental intervention.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medicine Greifswald

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcus Meinzer, Prof., PhD

Role: PRINCIPAL_INVESTIGATOR

Universitymedicine Greifswald

Locations

University Medicine Greifswald

Greifswald, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 40574976 (View on PubMed)

Other Identifiers

MS-CICS

Identifier Type: -

Identifier Source: org_study_id