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IRCT20221108056446N2 IRCT 2023-05-08 Esfahan University of Medical Sciences Dalfampridine in improving spasticity in patients with severe brain trauma Investigating the effectiveness of dalfampridine in improving spasticity in patients with severe brain trauma 2023-05-22 anticipated 80 Complete https://irct.ir/trial/69911 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: People are placed in 2 groups by random block method. In this way, the first 2 eligible people are selected and after obtaining consent, they enter to participate in the study. These 2 people are considered as a block of 2 and are sorted according to the last digit of the national code. The treatment methods are specified as A, B, and all combinations of 2 are specified, and after the last surgery, decoding is done for the last block, Blinding description: In the random block method, people are divided into two groups, and then medication is administered by the clinical caregiver with a specific code for them, and it is provided to the researcher (student). The researcher evaluates the patients using a questionnaire and records the results based on the patient code. Patients are also not aware of the type of surgery. Also, the analyzer is not aware of the group in which the patient is placed. 3 Severe traumatic brain injury. Intervention 1: Intervention group: Dalfampridine receptor (this drug is prescribed to the patient at a dose of 10 mg twice a day (every 12 hours)). Intervention 2: Control group: Placebo. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Esfahan University of Medical Sciences
kashani street
Isfahan Iran (Islamic Republic of) 83434-81839 +98 31 3233 0091 mahmoodkhani@mui.ac.ir Esfahan University of Medical Sciences scientific Mehdi Mahmoodkhani
Kashani street
Isfahan Iran (Islamic Republic of) 83434-81839 +98 31 3233 0091 mahmoodkhani@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Being between 18 and 65 years old More than a month has passed since the beginning of the trauma Having a level of consciousness less than 9 Not having a neurological or psychological disease before the trauma Presence of spasticity in the upper or lower limbs according to the Ashworth criteria 18 years 65 years Both Lack of consent of the patient's companion to enter the study Having a level of consciousness higher than 9 at the beginning of the trauma History of seizures, kidney and liver diseases S06.2 Diffuse traumatic brain injury Treatment - Drugs Treatment - Drugs Intervention group: Dalfampridine receptor (this drug is prescribed to the patient at a dose of 10 mg twice a day (every 12 hours)) Control group: Placebo Severity of muscle spasms. Timepoint: Before treatment, three and six months after the intervention. Method of measurement: Ashworth scale. Esfahan University of Medical Sciences Approved 2022-02-05 Isfahan University of Medical Sciences Hazar Jarib Street, Azadi Square Isfahan Isfehan Iran (Islamic Republic of)