Effects of 4-aminopyridine on attention and executive functions of patients with multiple sclerosis: Randomized, double-blind, placebo-controlled clinical trial. Preliminary report.

BACKGROUND: A high percentage of patients with multiple sclerosis present cognitive alterations. Because 4-aminopyridine improves nerve conduction and efficient synaptic connection could improve cognitive dysfunction. OBJECTIVE: To evaluate the efficacy on cognitive performance and safety of 4-aminopyridine administered to patients with relapsing-remitting multiple sclerosis. METHODS: A randomized, double-blind, placebo controlled clinical trial was conducted in patients with relapsing-remitting multiple sclerosis diagnosis according to the McDonald criteria. At the beginning and at the end of the treatment different tests were used to assess cognitive performance. Subsequently, patients were randomized 1:1 to receive treatment or placebo. A bootstrap-t test was proposed to test the effectiveness of cognitive performance, considering a p-value < 0.05 as statistically significant. RESULTS: Twenty-four patients were recruited of which 21 completed the trial, 11 with 4-aminopyridine and 10 with placebo treatment. No significant differences between groups in the initial assessments were observed. In terms of efficacy, the experimental group achieved significantly higher scores in attention span, verbal fluency, planning and graphics and constructive motion. CONCLUSIONS: 4-aminopyridine proved to be an effective treatment on cognitive aspects in patients with relapsing-remitting multiple sclerosis. Drug doses were shown to be safe with mild to moderate adverse events (ClinicalTrials.gov number, NCT02280096).

Clinical and demographic profile of traumatic spinal cord injury: a Mexican hospital-based study.

STUDY DESIGN: Review of clinical data. OBJECTIVES: The objective of this study was to describe the clinical and demographical profile of patients with traumatic spinal cord injury (TSCI) admitted to a single center. SETTING: Unidad de Medicina Física y Rehabilitación Centro, México. PARTICIPANTS: Patients with TSCI attending rehabilitation for the first time. INTERVENTION: Not applicable. MAIN MEASUREMENTS: Age, gender, educational level, occupational activity, causes of injury, level of injury, neurological level, injury severity and category were recorded. RESULTS: Four hundred and sixty-four clinical files of patients with TSCI were collected. The mean age was 37.9 ± 15.9 years; 78.2% (363/464) were male, basic educational level predominated in 63.6% (296/464) and 73.1% (339/464) were employed. A fall was the main mechanism of the injury in 41.6% (193/464), replacing automobile accidents from the first place. The mean age of persons who suffered falls was 44 ± 16 years. Injuries sustained by younger persons were due to violence (28.4 ± 10.1 years) and the cause of injury associated with male gender was violence. Thoracic level was most often affected (in 56.7%, 263/464) and neurological level C4 in 13.4% (62/464). In regard to the extent of the injury, lesions classified as American Spinal Injury Association A predominated (56.2%, 261/464) as with complete paraplegia in 43.3% (201/464). CONCLUSIONS: The mean age of our patients was 37 years. Men are affected in a higher proportion. Our population has <9 years of study. Physical labor was the usual pre-injury activity. The main mechanism of injury was falls. Thoracic spine was the most affected.