EMS_Rehab — Early Symptoms in Multiple Sclerosis: an Investigation Using fMRI and Gait Analysis to Develop Personalized Balance Training for People With Low Disability
LIFE - Research and Care Institute - Santa Lucia IRCCS •
SEP
Suivi actifNon applicable
Résumé
EMS_Rehab — Early Symptoms in Multiple Sclerosis: an Investigation Using fMRI and Gait Analysis to Develop Personalized Balance Training for People With Low Disability
est développé par LIFE - Research and Care Institute - Santa Lucia IRCCS.
Le traitement est actuellement en Non applicable.
Il est associé à SEP.
Son objectif thérapeutique principal est Traitement symptomatique.
Le statut actuel est : suivi actif.
À vérifier
Traitement symptomatique
Non applicable
LIFE - Research and Care Institute - Santa Lucia IRCCS
Non renseigné
Background
Many people with Multiple Sclerosis (MS) experience a hidden yet clinically significant symptom: impaired balance or a persistent feeling of instability, even during the early stages of the disease (Martin et al., 2006). Although these individuals may appear to walk normally, they often report feeling unsteady, avoiding crowded environments, or fearing falls. In some cases, however, balance deficits become overt and disabling, depending on the location and extent of lesions within the central nervous system. This heterogeneity complicates both the assessment and treatment of balance disorders in MS and highlights the need for personalized evaluation and rehabilitation strategies (Carpinella et al., 2022).
Because early balance impairments are often subtle, they tend to be underestimated in clinical practice and may remain untreated for months or even years. This delay can negatively affect confidence, mobility, safety, and overall quality of life. The present project seeks to address this gap by promoting early identification and intervention before substantial disability develops.
Project Objectives
The objectives of this project are:
To identify the mechanisms underlying early balance impairment in people with MS.
To develop and evaluate an early intervention based on Vestibular Physical Therapy (VPT) that specifically targets sensory reweighting and visuo-vestibular integration. The rehabilitation program is designed to improve gaze stability and saccadic velocity, both of which are essential for maintaining postural control and dynamic balance. In addition, functional magnetic resonance imaging (fMRI) will be used to investigate the neurophysiological mechanisms underlying the intervention, providing insight into how the brain adapts to vestibular stimulation.
If successful, this approach could enable clinicians to detect and treat balance impairments at an earlier stage, using objective and measurable changes in gait and brain function as biomarkers of rehabilitation efficacy.
Methodology
The study will recruit two groups of participants:
Individuals diagnosed with Multiple Sclerosis (Thompson et al., 2018; Wallace et al., 2025) with mild disability (Expanded Disability Status Scale, EDSS ≤ 2.5) who report balance complaints.
Healthy volunteers matched for age and sex.
At baseline (T0), all participants will undergo a comprehensive assessment including:
Structural and functional MRI with vestibular stimulation to investigate the integrity and functional organization of the vestibular network.
Instrumented gait analysis using wearable inertial sensors (Castiglia et al., 2025).
Validated clinical scales and questionnaires assessing objective balance performance, perceived stability, fear of falling, fall risk, and health-related quality of life.
Participants with MS will then be randomly assigned to one of two groups:
Intervention group: Participants will receive a structured Vestibular Physical Therapy (VPT) program consisting of 12 sessions (three sessions per week). Unlike conventional vestibular rehabilitation, this protocol specifically focuses on sensory reweighting and visuo-vestibular integration to enhance gaze stability, saccadic velocity, and postural control.
Control group: Participants will continue receiving standard clinical care for MS without additional vestibular rehabilitation during the initial study phase.
Following completion of the 12-session intervention, all participants will repeat the full assessment battery (T1) to evaluate changes in gait performance, balance, patient-reported outcomes, and brain function.
After a 4-week washout period, a crossover design will be implemented, with participants switching to the alternate treatment arm for an additional 12-session period, followed by a final assessment (T2). Participants initially assigned to the control group will not require a washout period before crossing over to the intervention, as they will not have received VPT during the first phase of the study.
Ce pourcentage n’est pas une probabilité de succès clinique.
Il mesure uniquement la force de la classification automatique de l’objectif scientifique. Le calcul part de 45 points, ajoute 7 points par unité de poids du mot-clé le plus fortement détecté, puis est plafonné à 95 %. Exemple : un score maximal de 2 donne 45 + (2 × 7) = 59 %.
Indices détectés : edss → Ralentissement de la progression, symptom → Traitement symptomatique
Ce score est heuristique et doit être vérifié dans le protocole ou une publication.
Description affichée depuis l’essai compatible NCT07805733, afin d’éviter le mélange entre plusieurs indications d’une même molécule.
Aucune incohérence majeure détectée entre la maladie, l’objectif et la description.
Transparence et qualité de la fiche
données vérifiables
ClassificationCohérente automatiquement
Confiance de la fiche100 %
Source principaleSource officielle ou publication indexée
Dernière vérification2026-09-01
Anomalies détectées0
Validation humaineValidation humaine non effectuée
Donnée issue d’une sourceDonnée normalisée automatiquementInterprétation algorithmique
Classification scientifique multi-axes
ne pas confondre statut et résultat
État de l’étudeRecrutement en cours
Disponibilité des résultatsRésultats à vérifier
InterprétationImpossible à déterminer
Niveau de preuveNon évaluable
Un essai terminé n’est pas nécessairement positif. Un essai arrêté n’est classé comme échec scientifique que lorsqu’un résultat ou une raison explicite le confirme.
Indicateurs factuels
sans score subjectif
Phase enregistréeNon applicable
Études associées1
Publications associées0
Statut consolidéSuivi actif
Aucune chance de succès, note d’innovation, potentiel thérapeutique ou probabilité de commercialisation n’est calculé tant qu’un modèle validé et des données suffisantes ne sont pas disponibles.
Historique factuel de la molécule
4 événement(s) daté(s)
Cette liste reprend uniquement les dates trouvées dans les registres et publications liés. Elle ne constitue pas une prévision.
Date
Événement
Source
2026-09-01
Dernière mise à jour des donnéesEMS_Rehab — Early Symptoms in Multiple Sclerosis: an Investigation Using fMRI and Gait Analysis to Develop Personalized Balance Training for People With Low Disability
EMS_Rehab — Early Symptoms in Multiple Sclerosis: an Investigation Using fMRI and Gait Analysis to Develop Personalized Balance Training for People With Low Disability
Non applicable
NOT_YET_RECRUITING
Non communiqué
LIFE - Research and Care Institute - Santa Lucia IRCCS
Ces sources sont proposées pour vérification. Les informations de la fiche doivent être confirmées dans les registres officiels ou les publications originales.