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Starting soon Not applicable

Spinal Cord Injury: Impact on Sensory, Motor, Behavioral and Cognitive Functions

NCT06887309 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-04-15
Last updated
2025-03-20

Condition(s) studied

Spinal Cord Injury

Investigational drug(s) / intervention(s)

MRINeuropsychological tests

MRI: MRI : anatomical (3DT1, 3D-FLAIR), functional (task-based and resting-state) and tractographic (multiband diffusion imaging) at three time points: one week, three months and twelve months after the spinal cord injury (SCI)

Neuropsychological tests: The following tests will be performed: the Montreal Cognitive Assessment (MOCA), the Montgomery-Åsberg depression rating scale (MADRS), the Medical Outcome Study Short Form 36 (SF-36)

Study summary

Spinal cord injury (SCI) causes a variety of sensory-motor deficits and neuropsychological consequences. Magnetic resonance imaging (MRI) reveals a reduction in the volume of the somato-sensory and motor cortices, as well as atrophy in the white matter bundles. In addition, disturbances in cerebral activity are observed in several areas, notably the motor cortex and the prefrontal cortex. The aim of this study is to understand the evolution of brain function after SCI in comparison with a control group of healthy volunteers.

We distinguish between patients with incomplete sensorimotor deficits (ASIA B,C,D) and complete sensorimotor deficits (ASIA A).

Both patient groups will have a multimodal assessment at 1 week, 3 months and 12 months after SCI with MRI and neuropsychological tests.

The group of healthy volunteers will only perform one MRI.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: * adults aged 18 to 80 * informed consent * patient with MCT in the previous week * clinical neurological examination demonstrating a sensory-motor deficit (the severity of which will define the group to which the patient belongs) associated with MCT. Exclusion criteria: * Impossibility of following the patient during the study period * Consent not obtained (adults, non-emancipated minors, persons unable to give consent, research carried out in emergency situations, etc.), * Not affiliated to a social security scheme, * Persons under court protection, * Other life-threatening systemic impairment, * Prior cognitive impairment, * Contraindication to MRI (pacemaker, metallic foreign body, etc.).

Primary outcome measure(s)

  • Sensory-motor and cognitive-behavioural impact at supra-spinal level on multimodal Magnetic Resonance Imaging (MRI) — From enrollment to the end of follow up at 12 months
    The difference in task-based functional supraspinal activation pattern evolution (delta beta, GLM) between patient groups (ASIA B,C,D vs. ASIA E) quantified by the students T-score (corrected for multiple comparison) that is associated to the variability of blood flow between the active (participant performs a task in the MRI) and resting (participant is at rest in the MRI) periods. The activity pattern is described by the size (number of voxels) and localization of activated regions.

Trial sites (1)

FacilityCityRegionStatus
CHU de Montpellier Montpellier France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06887309 on ClinicalTrials.gov ↗ ← All trials in France