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Search / Trial NCT07114809

Impact of Anodal tDCS and Virtual Reality on Cognitive Dysfunction in Patients With Multiple Sclerosis

Launched by OSPEDALE POLICLINICO SAN MARTINO · Aug 4, 2025

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Cognitive Impairment Multiple Sclerosis Exergaiming Virtual Reality T Dcs

ClinConnect Summary

This clinical trial is studying whether a combination of two treatments—transcranial direct current stimulation (tDCS), which uses gentle electrical currents on the head, and virtual reality (VR) exercises—can help improve thinking and memory problems in people with Multiple Sclerosis (MS). Cognitive difficulties are common in MS and can make daily life harder, so this study aims to see if these new technologies can offer better support than usual rehabilitation methods. The trial will involve 80 adults with MS who have some level of cognitive impairment. Half of the participants will receive real brain stimulation while doing VR-based exercises, and the other half will do the same exercises but with a fake (sham) stimulation to compare the effects.

To take part, individuals need to be between 18 and 60 years old, have a confirmed diagnosis of MS, and have a disability level that is not too severe. People with certain conditions like major psychiatric disorders, epilepsy, recent MS flare-ups, or poor vision will not be able to join. Participants can expect to attend 10 treatment sessions over two weeks, where they will play VR exercise games while receiving either real or sham brain stimulation. Their thinking abilities will be tested before the treatment, right after, and then again one and six months later to see if any improvements last over time. This study hopes to find a safe and effective way to help people with MS improve their cognitive function and quality of life.

Gender

ALL

Eligibility 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

About Ospedale Policlinico San Martino

Ospedale Policlinico San Martino is a leading academic medical center located in Genoa, Italy, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the institution integrates cutting-edge medical practices with a robust framework for patient care, fostering collaborations with academic institutions and industry partners. With a focus on diverse therapeutic areas, San Martino emphasizes patient safety, ethical standards, and the generation of high-quality scientific data to enhance treatment options and improve health outcomes.

Locations

Genova, , Italy

Genova, , Italy

Genova, , Italy

Patients applied

0 patients applied

Trial Officials

Laura Mori, MD, PhD

Principal Investigator

Ospedale Policlinico San Martino IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported