Post-Stroke Improvement of Motor Function

NCT ID: NCT03543917

Last Updated: 2018-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-08

Study Completion Date

2018-09-29

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

Conditions

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Cerebrovascular Accident

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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New Medication Combination

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

Group Type EXPERIMENTAL

Perfusion with New Combination Medication

Intervention Type COMBINATION_PRODUCT

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

Interventions

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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

Intervention Type COMBINATION_PRODUCT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundatia Bio-Forum

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Felician Stancioiu

Role: PRINCIPAL_INVESTIGATOR

Fundatia Bio-Forum

Locations

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Fundatia Bio-Forum

Bucharest, București, Romania

Site Status

Countries

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Romania

Other Identifiers

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PSIOM

Identifier Type: -

Identifier Source: org_study_id

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