- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02148887
Plasticity of Grey and White Matter in Response to Motor Skill Training in Healthy Individuals and Those With Spinal Cord Injury
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Functional recovery following human spinal cord injury (SCI) remains frustratingly limited and the majority of patients are left with severe impairments. While rehabilitative training has been shown to improve clinical outcome following SCI and has a major effect on patients' quality of life, the neuronal mechanisms underpinning neurological and functional recovery are not well understood.
Until recently, degenerative changes in components of the CNS remote to a SCI were thought to occur slowly (over years) and correlate with the degree of disability. Using longitudinal MRI protocols we have shown that these structural changes in fact occur early and progress both at the cord and brain level according to a specific spatial and temporal pattern (Freund et al 2013). It is thought that these trauma-induced structural changes progress retrogradely along central motor nerve fibres of the myelinated corticospinal tract (CST) and this is accompanied over time by shrinkage of corticospinal projecting neuronal bodies. Crucially, patients with less atrophy throughout the CST were those with better clinical recovery at twelve months. Despite this significant recovery advantage in some patients, all participants showed irreversible tissue loss, potentially hindering further recovery. Using the neuroimaging biomarkers established in the previous study cited above, we now aim to assess whether specific and intensive motor learning through tasks for the upper and lower limb might slow or reverse the atrophy seen in the sensorimotor system.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Zurich, Suisse, 8008
- Universitätsklinik Balgrist
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
Patients:
- Injury to the spinal cord which leads to any neurological deficits
- able to provide Informed consent
Controls:
- able to provide informed consent
Exclusion Criteria:
- Pregnancy
- MRI incompatible
- Neurologic or physiatric disorders
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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SCI patients with upper limb impairment - Upper limb training
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SCI patients with lower limb impairment - Lower limb training
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Healthy controls - Upper limb training
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Healthy controls - Lower limb training
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Healthy controls - No intervention
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
MRI parameters: tensor based morphometry, longitudinal relaxation rate, magnetisation transfer and diffusion index changes in the cervical and cranial corticospinal tract, basal ganglia, motor, premotor and parietal cortex.
Délai: MRI scans at weekly intervals (day 0, 7, 14, 28 and 84 after commencement of training)
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MRI scans at weekly intervals (day 0, 7, 14, 28 and 84 after commencement of training)
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Raw performance data in the upper and lower limb training task, recorded at each training session.
Délai: Training sessions 4x1hour per week for 4 weeks
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Training sessions 4x1hour per week for 4 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Overall activity levels as recorded by a worn accelerometer and clinical scoring tests repeated immediately following the first and final training scan sessions (Day 0 and 28) and the 84 day follow-up scan.
Délai: Training sessions 4x1hour per week for 4 weeks; clinical assessments at day 0, 28, 84
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Training sessions 4x1hour per week for 4 weeks; clinical assessments at day 0, 28, 84
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3D gait analysis will be performed on certain patients and control subjects at the first and final training scan sessions (Day 28) and the 84 day follow-up scan
Délai: 3D gait analysis at day 0, 28, 84
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3D gait analysis at day 0, 28, 84
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KEK-ZH-2013-0559/PB_2016-00624
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