Anodal tDCS plus virtual-reality exergaming for thinking problems in people with multiple sclerosis.
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.
This study will test whether adding mild brain stimulation (anodal tDCS) to virtual-reality exergaming can improve cognitive problems in adults with multiple sclerosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ospedale Policlinico San Martino Academic / other |
| Locations | 3 sites (Genova, Italy and 2 other locations) |
| Trial ID | NCT07114809 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, randomized, controlled study enrolling 80 people with multiple sclerosis and cognitive impairment, split into an experimental group and a sham-control group. All participants complete ten one-hour exergaming (non-immersive VR) sessions over two weeks, while the experimental group receives simultaneous anodal tDCS over the left dorsolateral prefrontal cortex and the control group receives sham stimulation. The anodal electrode is placed over the left DLPFC and the reference electrode over the right shoulder using a portable constant-current stimulator. Outcomes focus on changes in cognitive performance and related symptoms such as fatigue and quality of life.
Who should consider this trial
Good fit: Adults aged 18–60 with a confirmed MS diagnosis, cognitive impairment, and EDSS ≤ 7.5 who have no major psychiatric disorders, epilepsy, recent steroid-treated relapse, prior brain surgery, or severe bilateral visual loss are the intended participants.
Not a fit: People older than 60, with EDSS > 7.5, active epilepsy, recent MS relapse, major psychiatric disease, prior brain surgery, or poor bilateral vision are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combined tDCS and VR approach could improve thinking skills and reduce fatigue, offering a noninvasive add-on to existing rehabilitation for people with MS.
How similar studies have performed: Previous small studies of tDCS and of VR/exergaming in neurological conditions, including MS, have shown modest cognitive or functional benefits, but the simultaneous combination of anodal tDCS and VR is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Genova, Italy and 2 other locations
- Azienda Sanitaria Genovese — Genova, Italy, Italy (Recruiting)
- Ospedale Policlinico San Martino - IRCCS — Genova, Italy, Italy (Recruiting)
- Italian multiple sclerosis foundation — Genova, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Laura Mori, MD, PhD — Ospedale Policlinico San Martino IRCCS
- Study coordinator: Laura Mori, MD, PhD
- Email: laura.mori@hsanmartino.it
- Phone: *39 010 555 5645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.