- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02148887
Plasticity of Grey and White Matter in Response to Motor Skill Training in Healthy Individuals and Those With Spinal Cord Injury
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Zurich, Schweiz, 8008
- Universitätsklinik Balgrist
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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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.
Zeitfenster: 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.
Zeitfenster: Training sessions 4x1hour per week for 4 weeks
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Training sessions 4x1hour per week for 4 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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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.
Zeitfenster: 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
Zeitfenster: 3D gait analysis at day 0, 28, 84
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3D gait analysis at day 0, 28, 84
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KEK-ZH-2013-0559/PB_2016-00624
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Klinische Studien zur Investigating Spinal Atrophy in Patients With Spinal Injury
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Centre for Interdisciplinary Research in Rehabilitation...MitacsNoch keine RekrutierungRückenmarksverletzung | Gangstörung, Sensomotorik | Gangstörungen | Fortbewegung | Spinal Cord Injury SubacuteKanada