Clinical trial NCT06887309: Spinal Cord Injury: Impact on Sensory, Motor, Behavioral and Cognitive Functions
Official title: Cerebral Reorganizations Induced by Spinal Cord Injury Spinal Cord Injury: Multimodal Assessments of Sensory-motor and Cognitive-behavioral Functions. SUPRASPINAL
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Spinal cord injury
fMRI
DTI
MRI
diffusion tensor imaging
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: Lesions of the spinal cord induce sensory-motor deficits and have various neuropsychological effects. MRI shows a reduction in the volume of the somatosensory and motor cortices, as well as atrophy of the white matter bundles.

Disturbances in brain activity are observed in several critical areas. Patients may experience cognitive impairment and an increased risk of depression and anxiety. Although deep brain stimulation and transcranial magnetic stimulation have shown positive effects, the efficacy of these treatments remains limited, partly due to insufficient understanding of post-SCI brain changes.

The cognitive and behavioral consequences of spinal cord injury are poorly understood and mainly treated by symptomatic therapies, which are often ineffective and may have side effects.

A better understanding of brain networks and their plasticity after spinal cord injury could facilitate the development of targeted therapies, such as cortical or deep basal ganglia stimulation.

Eligibility criteria: 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 outcomes:
measure: Sensory-motor and cognitive-behavioural impact at supra-spinal level on multimodal Magnetic Resonance Imaging (MRI)
timeFrame: From enrollment to the end of follow up at 12 months
Secondary outcomes:
measure: Cortical volume in mm3
timeFrame: From enrollment to the end of follow up at 12 months
measure: Difference in evolution of functional motor patterns
timeFrame: From enrollment to the end of follow up at 12 months
measure: Montreal Cognitive Assessment score
timeFrame: From enrollment to the end of follow up at 12 months
measure: Difference in local resting-state connectivity (ALFF) between groups, quantified by the student T-score (corrected for multiple comparisons)
timeFrame: From enrollment to the end of follow up at 12 months
measure: Difference in local resting-state connectivity (ReHo) between groups, quantified by the student T-score (corrected for multiple comparisons)
timeFrame: From enrollment to the end of follow up at 12 months
measure: Difference in global resting-state connectivity (global efficiency - theory des graphs) between groups, quantified by the student T-score (corrected for multiple comparisons).
timeFrame: From enrollment to the end of follow up at 12 months
measure: Difference in anatomical connectivity
timeFrame: From inclusion to the last study visit at 12 months
measure: Measurement of cognitive-behavioral performance by MoCA test
timeFrame: From inclusion to the last study visit at 12 months
measure: Measurement of quality of life by SF-36
timeFrame: From inclusion to the last study visit at 12 months
measure: Beck Depression Inventory (BDI)
timeFrame: From inclusion to the last study visit at 12 months
measure: MADRS: Montgomery-Åsberg depression rating scale
timeFrame: From inclusion to the last study visit at 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
Study officials:
References: