Post-Stroke Improvement of Motor Function

Cerebrovascular Accident Clinical Trial

— PSIOM  

Official title:

Post-Stroke Improvement of Motor Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03543917
• Other study ID #: PSIOM
• Status: Completed
• Phase: Phase 1
• Start date: August 8, 2017
• Est. completion date: September 29, 2018

Study information

• Verified date: July 2018
• Source: Fundatia Bio-Forum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 29, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

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

Locations

Country	Name	City	State
Romania	Fundatia Bio-Forum	Bucharest	Bucuresti

Sponsors (1)

Lead Sponsor	Collaborator
Fundatia Bio-Forum

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 month after first administration of the combination