Cerebrovascular Accident
Conditions
Brief 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
Interventions
COMBINATION_PRODUCTPerfusion 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
Sponsors
Fundatia Bio-Forum
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NIHSS differential | 1 month after first administration of the combination | 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 |
Countries
Romania
Outcome results
None listed