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

Cerebral Reorganizations Induced by Spinal Cord Injury Spinal Cord Injury: Multimodal Assessments of Sensory-motor and Cognitive-behavioral Functions. SUPRASPINAL

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Diagnostic test: MRI; Behavioral: Neuropsychological tests

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: POULEN Gaëtan, Principal Investigator; Phone Number: +33 04 67 33 72 62; Email: g-poulen@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34000
    • CHU de Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Diagnostic test: 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); Behavioral: 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)
Active Comparator: 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.	Diagnostic test: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortical volume in mm3	Cortical volume in mm3	From enrollment to the end of follow up at 12 months
Difference in evolution of functional motor patterns	The difference in task-based functional supraspinal activation pattern evolution (delta beta, GLM) between patients and healthy controls 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
Montreal Cognitive Assessment score	The correlation, Pearsons r, between functional activity pattern changes (beta, GLM) and cognitive task performance (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)	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)	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
Difference in global resting-state connectivity (global efficiency - theory des graphs) between groups, quantified by the student T-score (corrected for multiple comparisons).	Difference in global resting-state connectivity (global efficiency - theory des graphs) 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 anatomical connectivity	Difference in anatomical connectivity (using the fractional anisotropy) between groups, quantified by the student T-score (corrected for multiple comparisons).	From inclusion to the last study visit at 12 months
Measurement of cognitive-behavioral performance by MoCA test	The Monreal Cognitive Assessment tes( MoCA) is a validated cognition test for the early detection of mild cognitive impairment (MCI). It assesses memory, visuospatial abilities, executive functions, attention, language and orientation. The score is comprised between 0 and 30. A score superior or equal to 26 is normal	From inclusion to the last study visit at 12 months
Measurement of quality of life by SF-36	The Medical Outcomes Study 36-item Short-Form Health Survey is a widely used, patient self-administered generic measure created to assess health-related quality of life (HRQoL) in the general population. Each item is scored between 0 to 100. A higher score indicates better quality of life.	From inclusion to the last study visit at 12 months
Beck Depression Inventory (BDI)	The BDI comprises 21 symptom and attitude items (a short version with 13 items exists), describing a specific behavioral manifestation of depression, graded from 0 to 3 by a series of 4 statements reflecting the degree of severity of the symptom. The score is comprised between 0 to 63. A high score means more severe depression	From inclusion to the last study visit at 12 months
MADRS: Montgomery-Åsberg depression rating scale	The MADRS scale is widely used to measure changes brought about by treatment for depression. It assesses the severity of symptoms in a wide range of areas, including mood, sleep and appetite, physical and psychological fatigue, and suicidal ideation. The score is comprised between 0 to 60. A score of 30 and more is associated to severe depression	From inclusion to the last study visit at 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): April 15, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: MRI; fMRI; DTI; Spinal cord injury; diffusion tensor imaging
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: RECHMPL23_0434; 2024-A00206-41 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No