Post-Stroke Improvement of Motor Function

Study Overview
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Brief Summary
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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
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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

Official Title
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Post-Stroke Improvement of Motor Function

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* Combination Product: Perfusion with New Combination Medication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults with CVA agreeing to treatment in person or by proxy signing of Informed Consent Form available for NIHSS evaluation Exclusion Criteria: allergy to any of the substances administered scheduled for surgery or other procedures not available for NIHSS evaluation after at least 48 hours from treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The new combination treatment is given to all consecutive patients and compared to literature and between groups (based on the time lapsed between CVA and treatment)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Medication Combination<br>Intervention: 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 | Combination Product: Perfusion with New Combination Medication<br>* Intravenous administration of Actovegin, vitamins B1, B6, B12, C, oxytocin/dexamethasone, calcium gluconate, etc in 250 ml normal saline administered during approximately 2 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIHSS differential | score differential on the National Institutes of Health Stroke Scale(NIHSS); total score is evaluated before treatment and 1 month after first treatment; NIHSS scores range between 0 (best score) and 42 (worst score); the differential quantifies an improvement in neurological function | 1 month after first administration of the combination |