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OpenTrials
Completed

NCT Number: NCT03543917

Post-Stroke Improvement of Motor Function

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

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Key information

Conditions

Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fundatia Bio-Forum

Bucharest, 040245, Romania

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perfusion with New Combination Medication

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Fundatia Bio-Forum

Other

Registry information

Acronym: PSIOM

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2018
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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