Impact of Anodal tDCS and Virtual Reality on Cognitive Dysfunction in
Impact of Anodal tDCS and Virtual Reality on Cognitive Dysfunction in Patients With Multiple Sclerosis: a Protocol of a Double Blind, Randomized, Prospective, Controlled Study.
What it found
No result yet.
What was tested
Treatment tested
- Experimental group (EG) performing Anodal-tDCS (A-tDCS) and VR
Placebo
- Sham Comparator: Control group (CG) performing sham-tDCS (S-tCDS) and VR
What it measured
Main measures
Revised Brief Visuo-Spatial Memory test (BVMT-R)
The patients will be evaluated at baseline, up to two weeks, one month and six months later
Thinking and memorySymbol digit modalities test (SDMT)
The patients will be evaluated at baseline, up to two weeks, one month and six months later.
Thinking and memoryCalifornia Verbal Learning test II edition (CVLT-II)
The patients will be evaluated at baseline, up to two weeks, one month and six months later
Thinking and memoryPaced Auditory Serial Addition Task 3" and 2" intervals (PASAT)
The patients will be evaluated at baseline, up to two weeks, one month and six months later
Thinking and memory
Other measures (3)
Multiple Sclerosis Quality of life (MSQoL)
The patients will be evaluated at baseline, up to two weeks, one month and six months later
Quality of life (reported by participants)Beck depression inventory scale (BDI)
The patients will be evaluated at baseline, up to two weeks, one month and six months later
Mood and sleepFatigue Severity Scale (FSS)
The patients will be evaluated at baseline, up to two weeks, one month and six months later
Fatigue
Who could take part
MS (type not specified) · 18 to 65
Show the full criteria
Inclusion criteria
1. MS diagnosis according to McDonald's criteria (McDonald 2017); 2. age between 18 and 60 (to avoid participants with possible CI due to aging); 3) disability score ≤7.5 at the Expanded Disability Status Scale (EDSS, Kurtzke 1983).
Exclusion criteria
1. subjects affected by major psychiatric disorders 2. epilepsy 3. previous brain surgery 4. MS relapse requiring steroid therapy in the previous two months 5. bilateral visual acuity \< 6/10
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
Cognitive impairment (CI) affects a large amount of patients with Multiple Sclerosis (PwMS) even in the early stages of the disease, increasing the perception of fatigue and compromising the quality of life. Different restorative interventions have been tried in order to alleviate CI, but with limited efficacy . Transcranial direct current stimulation (tDCS), represents a very promising alternative, or add-on, to the traditional rehabilitative approaches in MS. Notably, other novel technologies, such as Virtual Reality (VR) and Exergame, are emerging as a reinforcing tool to the rehabilitative treatment of PwMS. tDCS and VR can be combined in protocols aimed at achieving a better therapeutic benefit across different neurological diseases (Cassani 2020). The aim of our project is to explore the potential benefits of the simultaneous application of AtDCS and VR in the rehabilitation of cognitive impairment of PwMS. The VR approach will be implemented with a non-immersive VR system (exergames). As a secondary outcome, we wish to verify whether our protocol may extend its benefits over 6 months. Eighty PwMs with CI will be consecutively enrolled. Their cognitive status will be assessed by a neuropsychological battery: the Brief International Cognitive Assessment for MS and the Paced Auditory Serial Addition Test. To be considered cognitively impaired one has to abnormally score on at least two tests. Forty patients will be randomized to the experimental group (EG) or to the control group (CG). All the patients will undergo rehabilitative treatment with exergame (10 sessions for two consecutive weeks, 5 days per week). The EG patients will undergo a concurrent A-tDCS over the left dorsolateral prefrontal cortex, while the CG will receive a sham stimulation (S-tDCS). The patients will be evaluated at baseline, at the end of the treatment, one month and six months later. The statistical analyses will be done using repeated-measures ANOVA. Expected results: we hypothesize that the cognitive performances of both EG and CG groups will show an improvement in the cognitive performances. We will expect, however, a significative difference between the two groups, with patients in the EG group demonstrating better results than the CG group. Finally, we hypothesize the beneficial effects in EG patients will last at least one month after the end of the experiment.
Papers
Results
Impact of anodal tDCS and virtual reality on cognitive dysfunction in patients with Multiple Sclerosis: Protocol of a double blind, randomized, prospective, controlled study.PLoS One · 2025
Results
Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2015 Feb 12;2015(2):CD008349. doi: 10.1002/14651858.CD008349.pub3.Results
Cassani R, Novak GS, Falk TH, Oliveira AA. Virtual reality and non-invasive brain stimulation for rehabilitation applications: a systematic review. J Neuroeng Rehabil. 2020 Oct 31;17(1):147. doi: 10.1186/s12984-020-00780-5.Results
Solari A, Filippini G, Mendozzi L, Ghezzi A, Cifani S, Barbieri E, Baldini S, Salmaggi A, Mantia LL, Farinotti M, Caputo D, Mosconi P. Validation of Italian multiple sclerosis quality of life 54 questionnaire. J Neurol Neurosurg Psychiatry. 1999 Aug;67(2):158-62. doi: 10.1136/jnnp.67.2.158.Results
Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.Results
Charvet L, Shaw M, Dobbs B, Frontario A, Sherman K, Bikson M, Datta A, Krupp L, Zeinapour E, Kasschau M. Remotely Supervised Transcranial Direct Current Stimulation Increases the Benefit of At-Home Cognitive Training in Multiple Sclerosis. Neuromodulation. 2018 Jun;21(4):383-389. doi: 10.1111/ner.12583. Epub 2017 Feb 22.Results
Mattioli F, Bellomi F, Stampatori C, Capra R, Miniussi C. Neuroenhancement through cognitive training and anodal tDCS in multiple sclerosis. Mult Scler. 2016 Feb;22(2):222-30. doi: 10.1177/1352458515587597. Epub 2015 May 26.Results
Filippi M, Riccitelli G, Mattioli F, Capra R, Stampatori C, Pagani E, Valsasina P, Copetti M, Falini A, Comi G, Rocca MA. Multiple sclerosis: effects of cognitive rehabilitation on structural and functional MR imaging measures--an explorative study. Radiology. 2012 Mar;262(3):932-40. doi: 10.1148/radiol.11111299.Results
Mainero C, Caramia F, Pozzilli C, Pisani A, Pestalozza I, Borriello G, Bozzao L, Pantano P. fMRI evidence of brain reorganization during attention and memory tasks in multiple sclerosis. Neuroimage. 2004 Mar;21(3):858-67. doi: 10.1016/j.neuroimage.2003.10.004.Results
Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
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History
Started
Sept 2024
Main results due
Jan 2026
Finished
Jan 2026