Spinal Cord InjurySUPRASPINALNCT06887309
Spinal Cord Injury: Impact on Sensory, Motor, Behavioral and Cognitive Functions
A study testing MRI and Neuropsychological tests in people with Spinal Cord Injury, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- MRI and Neuropsychological tests
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2025to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
Read more
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.
Read the 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
- Being tested
- MRI, Neuropsychological tests
- Keywords
- Spinal cord injury, fMRI, DTI, MRI, diffusion tensor imaging
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic 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 testsBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of follow up at 12 months
Secondary outcomes (11)
Cortical volume in mm3
Cortical volume in mm3
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: From inclusion to the last study visit at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start15 Apr 2025 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887309
- Sponsor's protocol ID
- RECHMPL23_0434
- Other IDs
- 2024-A00206-41
- Acronym
- SUPRASPINAL
- Status last verified
- Mar 2025
- First submitted
- 7 Feb 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Reorganizations Induced by Spinal Cord Injury Spinal Cord Injury: Multimodal Assessments of Sensory-motor and Cognitive-behavioral Functions. SUPRASPINAL
- ClinicalTrials.gov ID
- NCT06887309
- Acronym / sponsor ID
- SUPRASPINAL / RECHMPL23_0434
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal cord injury, fMRI, DTI, MRI, diffusion tensor imaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients spinal cord injury with incomplete sensorimotor deficits ( ASIA B, C, D) and with complete | Experimental | Diagnostic Test: MRI, Behavioral: Neuropsychological testsExperimental: Patients spinal cord injury with incomplete sensorimotor deficits (ASIA B, C, D) and with complete sensorimotor deficits (ASIA A) |
| Healthy control group | Active comparator | Diagnostic Test: MRIMRI : 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI : 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) | Diagnostic test | Healthy control group, Patients spinal cord injury with incomplete sensorimotor deficits ( ASIA B, C, D) and with complete |
| Neuropsychological testsThe 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) | Behavioural | Patients spinal cord injury with incomplete sensorimotor deficits ( ASIA B, C, D) and with complete |
Primary outcome
Sensory-motor and cognitive-behavioural impact at supra-spinal level on multimodal Magnetic Resonance Imaging (MRI)
Time frame: From enrollment to the end of follow up at 12 months
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.
11 secondary outcomes
Cortical volume in mm3
Time frame: From enrollment to the end of follow up at 12 months
Difference in evolution of functional motor patterns
Time frame: From enrollment to the end of follow up at 12 months
Montreal Cognitive Assessment score
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: From enrollment to the end of follow up at 12 months
Difference in anatomical connectivity
Time frame: From inclusion to the last study visit at 12 months
Measurement of cognitive-behavioral performance by MoCA test
Time frame: From inclusion to the last study visit at 12 months
Measurement of quality of life by SF-36
Time frame: From inclusion to the last study visit at 12 months
Beck Depression Inventory (BDI)
Time frame: From inclusion to the last study visit at 12 months
MADRS: Montgomery-Åsberg depression rating scale
Time frame: From inclusion to the last study visit at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and Neuropsychological tests in people with Spinal Cord Injury, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact POULEN Gaëtan, Principal Investigator (+33 04 67 33 72 62, g-poulen@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory-motor and cognitive-behavioural impact at supra-spinal level on multimodal Magnetic Resonance Imaging (MRI) (time frame: From enrollment to the end of follow up at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.