Trial | NCT03543917  Report issue

Official Title

Post-Stroke Improvement of Motor Function

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    17
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
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
Study Started
Aug 08
2017
Primary Completion
Aug 30
2018
Study Completion
Sep 29
2018
Last Update
Nov 19
2018

Combination Product Perfusion with New Combination Medication [thiamine, pyridoxine, cobalamin, vitamin c, oxytocin (syntocinon), dexamethasone, calcium gluconate, calf serum]

Intravenous administration of Actovegin, vitamins B1, B6, B12, C, oxytocin/dexamethasone, calcium gluconate, etc in 250 ml normal saline administered during approximately 2 hours

New Medication Combination Experimental

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

Criteria 

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
No Results Posted