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

NCT ID: NCT06887309

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2027-10-01

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients spinal cord injury with incomplete sensorimotor deficits ( ASIA B, C, D) and with complete

Experimental: Patients spinal cord injury with incomplete sensorimotor deficits (ASIA B, C, D) and with complete sensorimotor deficits (ASIA A)

Group Type: EXPERIMENTAL

MRI

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: BEHAVIORAL

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)

Healthy control group

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.

Group Type: ACTIVE_COMPARATOR

MRI

Intervention Type: DIAGNOSTIC_TEST

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)

Interventions

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)

Intervention Type: DIAGNOSTIC_TEST

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)

Intervention Type: BEHAVIORAL

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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Montpellier

Montpellier, , France

Countries

France

Central Contacts

POULEN Gaëtan, Principal Investigator

Role: CONTACT

g-poulen@chu-montpellier.fr

+33 04 67 33 72 62

Other Identifiers

2024-A00206-41

Identifier Type: OTHER

Identifier Source: secondary_id

RECHMPL23_0434

Identifier Type: -

Identifier Source: org_study_id