Post-Stroke Improvement of Motor Function (PSIOM)

November 16, 2018 updated by: Fundatia Bio-Forum
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Bucuresti
      • Bucharest, Bucuresti, Romania, 040245
        • Fundatia Bio-Forum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIHSS differential
Time Frame: 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
1 month after first administration of the combination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundatia Bio-Forum

Investigators

  • Principal Investigator: Felician Stancioiu, Fundatia Bio-Forum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2017

Primary Completion (Actual)

August 30, 2018

Study Completion (Actual)

September 29, 2018

Study Registration Dates

First Submitted

May 21, 2018

First Submitted That Met QC Criteria

May 21, 2018

First Posted (Actual)

June 1, 2018

Study Record Updates

Last Update Posted (Actual)

November 19, 2018

Last Update Submitted That Met QC Criteria

November 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSIOM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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