Clinical trial NCT04667221: Cognitive Improvement Through tDCS for Patients With Multiple Sclerosis
Official title: Cognitive Improvement Through Transcranial Direct Current Stimulation for Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, balanced crossover design.
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Reaction Times in symbol-digit modalities test.
timeFrame: 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:
measure: Hit Rate in symbol-digit modalities test.
timeFrame: 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))
measure: Baseline performance in symbol-digit modalities test.
timeFrame: Assessment at baseline (Day 0, before stimulation).
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
Study officials:
affiliation: Universitymedicine Greifswald
name: Marcus Meinzer, Prof., PhD
role: PRINCIPAL_INVESTIGATOR
References: