Post-Stroke Improvement of Motor Function

Phase 1

Completed

• Conditions: Cerebrovascular Accident

• Registration Number: NCT03543917
• Lead Sponsor: Fundatia Bio-Forum

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

Study Timeline

• Study Start: 2017-08-08
• Study First Submitted: 2018-05-21
• Study First Submitted QC: 2018-05-21
• Study First Posted: 2018-06-01
• Status Verified: 2018-07
• Primary Completion: 2018-08-30
• Study Completion: 2018-09-29
• Last Update Submitted: 2018-11-16
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
NIHSS differential	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

Trial Locations

Locations (1)

Fundatia Bio-Forum; 🇷🇴 Bucharest, Bucuresti, Romania