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Post-Stroke Improvement of Motor Function (PSIOM)

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Phase 1
Locations
Romania
Study Type
Interventional
Intervention
Perfusion with New Combination Medication
Sponsored by
Fundatia Bio-Forum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fundatia Bio-Forum

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

New Medication Combination

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 21, 2018
Last Updated
November 16, 2018
Sponsor
Fundatia Bio-Forum
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1. Study Identification

Unique Protocol Identification Number
NCT03543917
Brief Title
Post-Stroke Improvement of Motor Function
Acronym
PSIOM
Official Title
Post-Stroke Improvement of Motor Function
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
September 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundatia Bio-Forum

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
New Medication Combination
Arm Type
Experimental
Arm Description
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
Intervention Type
Combination Product
Intervention Name(s)
Perfusion with New Combination Medication
Intervention Description
Intravenous administration of Actovegin, vitamins B1, B6, B12, C, oxytocin/dexamethasone, calcium gluconate, etc in 250 ml normal saline administered during approximately 2 hours
Primary Outcome Measure Information:
Title
NIHSS differential
Description
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
Time Frame
1 month after first administration of the combination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felician Stancioiu
Organizational Affiliation
Fundatia Bio-Forum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundatia Bio-Forum
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
040245
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
No

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Post-Stroke Improvement of Motor Function

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