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

Primary Purpose

Multiple Sclerosis

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Active transcranial direct current stimulation
Sham transcranial direct current stimulation
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • University Medicine Greifswald

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Sham Comparator

Sham Comparator

Arm Label

Anodal transcranial direct current stimulation

Cathodal transcranial direct current stimulation

Sham transcranial direct current stimulation for anodal group

Sham transcranial direct current stimulation for cathodal group

Arm Description

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

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

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.

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.

Outcomes

Primary Outcome Measures

Reaction Times in symbol-digit modalities test.
Reaction times in milliseconds for the performance of the symbol-digit modalities test.

Secondary Outcome Measures

Hit Rate in symbol-digit modalities test.
Hit rate in percentage of correct responses in the symbol-digit modalities test.
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.

Full Information

First Posted
December 8, 2020
Last Updated
May 11, 2023
Sponsor
University Medicine Greifswald
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1. Study Identification

Unique Protocol Identification Number
NCT04667221
Brief Title
Cognitive Improvement Through tDCS for Patients With Multiple Sclerosis
Acronym
MS-CICS
Official Title
Cognitive Improvement Through Transcranial Direct Current Stimulation for Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, balanced crossover design.
Masking
ParticipantInvestigator
Masking Description
Participants and investigators are blinded according to the sham / active stimulation.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anodal transcranial direct current stimulation
Arm Type
Experimental
Arm Description
Patients will be bilaterally stimulated with anodal tDCS at the parietal cortex (Brodmann Area 7).
Arm Title
Cathodal transcranial direct current stimulation
Arm Type
Experimental
Arm Description
Patients will be bilaterally stimulated with cathodal tDCS at the parietal cortex (Brodmann Area 7).
Arm Title
Sham transcranial direct current stimulation for anodal group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Sham transcranial direct current stimulation for cathodal group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active transcranial direct current stimulation
Other Intervention Name(s)
non-invasive brain stimulation, transcranial electrical stimulation
Intervention Description
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
Intervention Name(s)
Sham transcranial direct current stimulation
Other Intervention Name(s)
non-invasive brain stimulation, transcranial electrical stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reaction Times in symbol-digit modalities test.
Description
Reaction times in milliseconds for the performance of the 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))
Secondary Outcome Measure Information:
Title
Hit Rate in symbol-digit modalities test.
Description
Hit rate in percentage of correct responses in the 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))
Title
Baseline performance in symbol-digit modalities test.
Description
Baseline performance of paper-pencil version of the symbol-digit modalities test as a predictor for the stimulation effect.
Time Frame
Assessment at baseline (Day 0, before stimulation).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. standard tDCS exclusion criteria (e.g. cardiac pacemaker, metal implants in head region, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Meinzer, Prof., PhD
Organizational Affiliation
Universitymedicine Greifswald
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medicine Greifswald
City
Greifswald
ZIP/Postal Code
17489
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Cognitive Improvement Through tDCS for Patients With Multiple Sclerosis

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