Cognitive Improvement Through tDCS for Patients With Multiple Sclerosis (MS-CICS)

May 11, 2023 updated by: University Medicine Greifswald

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Greifswald, Germany, 17489
        • University Medicine Greifswald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.
  • standard tDCS exclusion criteria (e.g. cardiac pacemaker, metal implants in head region, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anodal transcranial direct current stimulation
Patients will be bilaterally stimulated with anodal tDCS at the parietal cortex (Brodmann Area 7).
Device: 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.
Other Names:
  • transcranial electrical stimulation
  • non-invasive brain stimulation
Experimental: Cathodal transcranial direct current stimulation
Patients will be bilaterally stimulated with cathodal tDCS at the parietal cortex (Brodmann Area 7).
Device: 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.
Other Names:
  • transcranial electrical stimulation
  • non-invasive brain stimulation
Sham Comparator: 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.
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.
Other Names:
  • transcranial electrical stimulation
  • non-invasive brain stimulation
Sham Comparator: 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.
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.
Other Names:
  • transcranial electrical stimulation
  • non-invasive brain stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
Hit rate in percentage of correct responses in 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))
Baseline performance in symbol-digit modalities test.
Time Frame: Assessment at baseline (Day 0, before stimulation).
Baseline performance of paper-pencil version of the symbol-digit modalities test as a predictor for the stimulation effect.
Assessment at baseline (Day 0, before stimulation).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Investigators

  • Principal Investigator: Marcus Meinzer, Prof., PhD, Universitymedicine Greifswald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2020

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 8, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-CICS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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