Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04667221
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-15
First Post:
2020-12-08
Brief Title:
Cognitive Improvement Through tDCS for Patients With Multiple Sclerosis
Sponsor:
University Medicine Greifswald
Organization:
University Medicine Greifswald
Study Overview
Official Title:
Cognitive Improvement Through Transcranial Direct Current Stimulation for Patients With Multiple Sclerosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MS-CICS
Brief Summary:
Multiple sclerosis MS is a chronic inflammatory disease with around 200000 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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None