Dalfampridine in improving spasticity in patients with severe brain trauma

Phase 3

Recruiting

• Conditions: Severe traumatic brain injury.; Diffuse traumatic brain injury; S06.2

• Registration Number: IRCT20221108056446N2
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of muscle spasms. Timepoint: Before treatment, three and six months after the intervention. Method of measurement: Ashworth scale.