NCT03543917

Post-Stroke Improvement of Motor Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Fundatia Bio-Forum · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Open-label clinical study where all new patients presenting with cerebrovascular accidents and consenting to treatment are given intravenously a new combination of medications. Patients are evaluated neurologically with NIHSS scores before treatment administration and at 1 month after the first treatment. Further evaluations at 6 months after treatment by NIHSS and Barthel scores are ongoing

Detailed description

Patients with cerebrovascular accidents (CVA), ischemic (including those with hemorrhagic transformation), are given a new combination of medications which aims to improve neuronal survival, stimulate mitochondrial genesis and the formation of new synapses. This combination is given as an intravenous perfusion with a 2-hr duration and consists of vitamins B1, B6, B12, C, Actovegin, etc. Before treatment a NIHSS score is given. Each patient receives 3-4 such perfusions in 1 month and afterwards another NIHSS score is obtained. Patients are monitored afterwards and those who show improvements receive more such treatments, and new NIHSS and Barthel scores are obtained. Patients are grouped on the basis of the time interval between CVA occurence and first treatment: * Group 1: 0-35 days * Group 2: 36-100 days * Group 3: 101-360 days Improvement of motor function is compared using NIHSS scores between groups, and between literature and groups

Conditions

• Cerebrovascular Accident

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Perfusion with New Combination Medication	Intravenous administration of Actovegin, vitamins B1, B6, B12, C, oxytocin/dexamethasone, calcium gluconate, etc in 250 ml normal saline administered during approximately 2 hours

Timeline

• Start date: 2017-08-08
• Primary completion: 2018-08-30
• Completion: 2018-09-29
• First posted: 2018-06-01
• Last updated: 2018-11-19

Locations

1 site across 1 country: Romania