Investigating brain activity during rehabilitation exercises for multiple sclerosis
Investigate Neuro-rehabilitation Active Ingredients of Specific Task-oriented Training In People With Multiple Sclerosis With Different Challenging Conditions and Extrinsic Feedbacks
This study is testing how brain activity changes during rehabilitation exercises in people with multiple sclerosis and healthy volunteers to see if it can help improve their mobility and brain function.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 3 sites (Genova and 2 other locations) |
| Trial ID | NCT06826638 on ClinicalTrials.gov |
What this trial studies
This project aims to explore cortical activity during task-oriented exercises in individuals with multiple sclerosis and healthy volunteers using advanced imaging techniques. By observing brain activity in real-time during rehabilitation sessions, the study seeks to enhance understanding of the neural mechanisms that contribute to functional improvements. It will involve 40 healthy subjects and 20 individuals with multiple sclerosis, focusing on how rehabilitation impacts mobility and brain plasticity. The findings could provide insights into optimizing rehabilitation strategies for better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 to 60 with a stable diagnosis of multiple sclerosis and healthy right-handed volunteers.
Not a fit: Patients with severe joint disorders, major depression, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation techniques that enhance recovery and functional abilities in patients with multiple sclerosis.
How similar studies have performed: Previous studies have shown promise in understanding brain activity related to rehabilitation, but this approach of real-time observation during exercises is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * subjects between 18 and 60 years of age, * diagnosis of MS (McDonald criteria, Thompson et al, 2018), stable disease course without worsening more than 1 EDSS point over the last 3 months, EDSS between 3 and 4.5 points, * healthy right-handed volunteers, * able to release a written informed consent. Exclusion Criteria: * Unable to comprehend the aims of the study and to follow test instructions; * Diagnosis of major depression (DSM-5); * Severe joint and/or bone disorders interfering with balance and gait (based upon clinical judgment); * Cardiovascular diseases; * Severe visual impairments interfering with the execution of the protocol; * epilepsy; * intake of neuroleptic and antiepileptic drugs.
Where this trial is running
Genova and 2 other locations
- Università di Genova — Genova, Italy (Recruiting)
- IRCCS Santa Maria Nascente - Fondazione Don Carlo Gnocchi — Milan, Italy (Recruiting)
- Università degli Studi di Milano — Milan, Italy (Active_not_recruiting)
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.