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

NCT06887309 | Not Yet Recruiting DMC

• 2 other identifiers: RECHMPL23_04342024-A00206-41
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

Spinal cord injury; fMRI; DTI; MRI; diffusion tensor imaging

Outcome Measures

Primary Outcomes (1)

• Sensory-motor and cognitive-behavioural impact at supra-spinal level on multimodal Magnetic Resonance Imaging (MRI)

  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.

  From enrollment to the end of follow up at 12 months

Secondary Outcomes (11)

• Cortical volume in mm3

  From enrollment to the end of follow up at 12 months

• Difference in evolution of functional motor patterns

  From enrollment to the end of follow up at 12 months

• Montreal Cognitive Assessment score

  From enrollment to the end of follow up at 12 months

• Difference in local resting-state connectivity (ALFF) between groups, quantified by the student T-score (corrected for multiple comparisons)

  From enrollment to the end of follow up at 12 months

• Difference in local resting-state connectivity (ReHo) between groups, quantified by the student T-score (corrected for multiple comparisons)

  From enrollment to the end of follow up at 12 months

Study Arms (2)

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

EXPERIMENTAL

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

Diagnostic Test: MRI; Behavioral: Neuropsychological tests

Healthy control group

ACTIVE COMPARATOR

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.

Diagnostic Test: MRI

Interventions

MRI 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)

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

Neuropsychological tests 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)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU de Montpellier

Montpellier, 34000, France

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Central Study Contacts

POULEN Gaëtan, Principal Investigator

CONTACT

+33 04 67 33 72 62; g-poulen@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: March 20, 2025
• Study Start: April 15, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

FR (1)