Post-Stroke Improvement of Motor Function (PSIOM)

Fundatia Bio-Forum

Status and phase: Completed; Phase 1

Conditions: Cerebrovascular Accident

Treatments: Combination Product: Perfusion with New Combination Medication

Study type: Interventional

Funder types: Other

Identifiers

NCT03543917

PSIOM

Details and patient eligibility

About

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

Full 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

Enrollment: 17 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

New Medication Combination

Experimental group

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

Treatment:

Combination Product: Perfusion with New Combination Medication