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

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Not yet enrolling

Conditions

Spinal Cord Injury

Treatments

Behavioral: Neuropsychological tests
Diagnostic Test: MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT06887309
2024-A00206-41 (Other Identifier)
RECHMPL23_0434

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.).

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Patients spinal cord injury with incomplete sensorimotor deficits ( ASIA B, C, D) and with complete
Experimental group
Description:
Experimental: Patients spinal cord injury with incomplete sensorimotor deficits (ASIA B, C, D) and with complete sensorimotor deficits (ASIA A)
Treatment:
Diagnostic Test: MRI
Behavioral: Neuropsychological tests
Healthy control group
Active Comparator group
Description:
MRI : anatomical (3DT1, 3D-FLAIR), functional (task-based and resting-state) and tractographic (multiband diffusion imaging). MRI will be done once for the healthy volunteer control group.
Treatment:
Diagnostic Test: MRI

Trial contacts and locations

1

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Central trial contact

POULEN Gaëtan, Principal Investigator

Data sourced from clinicaltrials.gov

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