Not Yet Recruiting

NCT Number: NCT06532760

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

healthy volonteers group: Inclusion Criteria

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

Exclusion criteria

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:

Inclusion criteria

- Male or female

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

Exclusion criteria

Pregnant or breast-feeding patient
Absence of consent from the volunteer or his/her trusted support person
Patient under guardianship or trusteeship
Brain injury due to cranioencephalic trauma with a Glasgow score of less than 14 on reassessment, associated with a cerebral CT scan of grade III or less on the Marshall classification
Presence of another neurological or mental disorder or neurodegenerative disease

Brain injury patients Group:

Inclusion criteria

Male or female
Aged 18 to 75
Have suffered a traumatic brain injury (TBI) with a proven acute brain injury according to the following characteristics:
Glasgow score less than 13 on admission without metabolic cause in the context of head trauma
Cerebral CT scan at least grade II according to Marshall classification
Absence of traumatic spinal lesion threatening the integrity of the spinal canal assessed by neuroradiological examination (CT and/or MRI)
Signed consent for emergency and continuation of study
ASIA E score

Exclusion criteria

Pregnant or breast-feeding patient
Absence of consent from the volunteer or his/her trusted support person
Patient under guardianship
ASIA score A to D
Presence of another neurological or mental disorder or neurodegenerative disease

Treatment and study plan

Blood sampling

Other

Blood sampling to study sodium fragment kinetics

Primary outcomes

Detect the presence of sodium fragments in blood samples from patients

Time frame: 6 hours to 6 months post-injury

Secondary outcomes

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

Time frame: 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

Time frame: 3 and 6 months-post-injury

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre-Hugues ROCHE

CONTACT

[email protected]

0033491365135

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

Identification Des Fragments de Canaux Sodiques Comme Biomarqueurs sériques d'Une lésion Traumatique du système Nerveux Central

Acronym: SpasT-SCI-T

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Aug 1, 2024
Registry last updated: Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting