The efficacy of fingolimod in enhancing neurological recovery after traumatic spinal cord injury

Investigating the efficacy of Fingolimod drug in increasing recovery after traumatic spinal cord injury

Block Randomized, controlled Clinical trial with 36 participants, superiority,blinded (double blind),Phase II study

Patients traumatic spinal cord injury based on clinical examinations and imaging, who were admitted to Mashhad Kamyab Hospital during the first 8 hours of spinal cord injury, after obtaining informed consent are randomly divided into two groups : 1- Intervention (Methylprednisolone with fingolimod 2- control group (with placebo). All patients will be evaluated in terms of sensory-motor status and sphincter function before starting the intervention. Blinding method in this study is double blind .

Inclusion criteria: 1- Age 20 to 60 years 2- Stable hemodynamic conditions 3- Referral in the first 8 hours after traumatic spinal cord injury Exclusion criteria: Non-traumatic spinal cord injury Damage with cold or hot weapons

intervention group: patients will receive Methylprednisolone loading dose (30 mg/kg) and maintenance (5.4 mg/kg/hour) for 24 or 48 hours based on the time interval between the trauma and administration. Patients will also receive Fingolimod (0.5 mg tablet) twice according to the protocol (the first dose within the first 8 hours after the spinal cord injury and the second dose 24 hours after the first dose). control group will only receive Methylprednisolone both loading and maintenance.

Examining the sensorimotor status of patients Based on the American Spinal Injury Association Impairment Scale (AISA) Examining the sphincter status of patients (Clinical examination and urodynamic study)

In this study, allocation of 36 eligible patients into two arms is done by block method. A number of 6 random blocks with size of 6 and with different sequences were prepared (from the site https://www.sealedenvelope.com/simple-randomiser/v1/lists) and the content of each block was sealed in an envelope. on admission, the blocks are opened and depending on the sequence of its content, the desired person is placed in one of the arms of the study. In the same way, after the completion of the first block, the second block is randomly selected and this continues until the last block . At the end, by assigning the last sheet of the last block, the patients are grouped equally in the two arms of the study and the balance between the groups is established.

In this study, blinding is done in a double-blind manner . Patients with traumatic spinal cord injury will be admitted and informed consent will be obtained.The participants will be randomly assigned to one of the intervention or control groups without their knowledge.In the intervention group, the patient receives routine treatment and Fingolimod capsule. In the control group, the patient will receive routine treatment and also placebo, which is similar to Fingolimod in terms of shape, color, smell and administration method.

Part of the data, such as information on the main outcome, can be shared after de-identifying individuals

The access period will start 6 months after the publication of the results

It will be available only to researchers working in academic and scientific institutions

The use of data and results to expand the study on the therapeutic effects of Fingolimod in spinal cord injuries is unimpeded

Applicants can go to the Neurosurgery Department of Mashhad University of Medical Sciences located on Ahmed Abad Street, Qaim Hospital, 1st floor to receive the desired documents or data, or submit their request via email or phone call: Nazarpoursh991@yahoo.com 00985138012759

After introducing and sending the documents related to the place of study or employment, the latest academic degree and the goals resulting from the use and analysis of the data of this study, the applicant will be able to access the documents within a maximum period of two working weeks.