Identification of Sodium Channel Fragments as Serum Biomarkers of a Traumatic Central Nervous System Injury

NCT06532760 | Not Yet Recruiting

• 1 other identifier: RCAPHM21_0427
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Following spinal cord injury (SCI), 75% of patients develop spasticity of the limbs characterized by an increase in muscle tone causing severe pain. Currently, the diagnosis of spinal cord injury is based on clinical and radiological evaluation by CT and MRI, but there is no reliable biomarker capable of predicting the medium and long-term clinical course in terms of emergence and severity of spasticity and neurological recovery. Recently, pre-clinical models in rats have shown the presence of protein fragments from a cleavage of sodium channels in spinal cords below the level of injury. Other studies have also shown the presence of these fragments in the brain following a head injury. These fragments would be potentially useful as a biomarker of the SCI. The detection of sodium fragments would be potentially useful as a biomarker of a lesion of the central nervous system (spinal cord or brain) and of the severity of the spasticity in patients suffering from SCI. The main objective of this study is to detect the presence of sodium fragments in blood samples from patients with SCI from or brain injury. The secondary objectives will be to study the post-lesional / injury kinetics of sodium fragments, to determine their diagnostic values in terms of the severity of the injury, and their prognostic values concerning the emergence of the spasticity in patients with SCI. An initial prospective cohort will include 40 people. The fragments of sodium channels will be measured in blood samples taken within 6 hours post-trauma, then 1, 3, 5 and 7 days post-trauma, as well as 3 and 6 months post-trauma. The overall expression of sodium fragments will be compared to that of healthy controls. Participants will be recruited in the acute care units of the AP-HM. Participants will be recruited from the main acute care units of the AP-HM. Post-traumatic follow-up assessments during their rehabilitation will be carried out at 3 and 6 months in the neurosurgery department of North Hospital from APHM.

Conditions

Spinal Cord Injury; Spasticity, Muscle; Brain Injuries

Outcome Measures

Primary Outcomes (1)

• Detect the presence of sodium fragments in blood samples from patients

  6 hours to 6 months post-injury

Secondary Outcomes (2)

• kinetics of sodium fragments in patients with acute SCI and in traumatic brain injury patients in the post-trauma period

  6 hours to 6 months post-injury

• To correlate measurements of sodium fragments in blood from 6 hours to 6 months post-injury with the occurence of spasticity in the post-trauma period

  3 and 6 months-post-injury

Study Arms (3)

Patients with Spinal cord injury

EXPERIMENTAL

Other: Blood sampling

Patients with Brain Injury

ACTIVE COMPARATOR

Other: Blood sampling

Healthy volunteers

ACTIVE COMPARATOR

Other: Blood sampling

Interventions

Blood sampling OTHER

Blood sampling to study sodium fragment kinetics

Healthy volunteers; Patients with Brain Injury; Patients with Spinal cord injury

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female
• Age 18 to 75
• free of central or peripheral nervous system trauma
• Having given free and informed consent
• Beneficiary of or affiliated to a social security scheme

You may not qualify if:

• Pregnant or breast-feeding women
• Person under guardianship or curatorship
• Diagnosis of a neurological disorder
• Diagnosis of a psychiatric disorder
• Diagnosis of a neurodegenerative disease
• Spinal Cord injury patients group:
• Aged 18 to 75
• Beneficiary of or affiliated to a social security scheme
• Having suffered within 6 hours a trauma with an acute LME confirmed according to the following characteristics:
• Lesion located at C4-T12 level and radiologically documented (CT scan and/or spinal MRI performed within 6 hours)
• Complete or incomplete according to the American Spinal Injury Association impairment scale (ASIA A to D)
• Signed consent for emergency and continuation of study
• Pregnant or breast-feeding patient
• Absence of consent from the volunteer or his/her trusted support person
• Patient under guardianship or trusteeship

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Related Publications (1)

• Baucher G, Liabeuf S, Brocard C, Ponz A, Baumstarck K, Troude L, Leone M, Roche PH, Brocard F. The SpasT-SCI-T trial protocol: Investigating calpain-mediated sodium channel fragments as biomarkers for traumatic CNS injuries and spasticity prediction. PLoS One. 2025 May 21;20(5):e0319635. doi: 10.1371/journal.pone.0319635. eCollection 2025.

  PMID: 40397864 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Muscle Spasticity; Brain Injuries

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Craniocerebral Trauma

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• François CREMIEUX

  francois.cremieux@ap-hm.fr

  STUDY DIRECTOR

Central Study Contacts

Pierre-Hugues ROCHE

CONTACT

0033491365135; Pierre-hugues.ROCHE@ap-hm.fr

Study Design

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

Model Details: 3 groups

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 1, 2024

Record last verified: 2024-07