Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07043686

Effect of Cerebrolysin on Early Rehabilitation After Ischemic Stroke at the Department of Vascular Neurology and Intensive Neurological Therapy, University Medical Centre Ljubljana

Led by University Medical Centre Ljubljana · Updated on 2025-07-09

30

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effects of Cerebrolysin during early rehabilitation in patients with moderate to severe neurological impairment after an acute ischemic stroke. The study aims to determine how Cerebrolysin, given in addition to standard stroke care, impacts recovery and neurological outcomes at discharge and 90 days post-stroke. This research is conducted at the Department of Vascular Neurology and Intensive Neurological Therapy, University Medical Centre Ljubljana, focusing on a specific patient group with NIHSS scores between 6 and 12. Patients in the study are divided into two groups: one receiving Cerebrolysin plus standard care, and a control group receiving only standard treatment. Cerebrolysin is given as a 30 ml intravenous infusion daily for 10 consecutive days, diluted to 100 ml with saline and infused over 15 minutes. Both groups receive standard stroke treatments including reperfusion therapy, secondary prevention, and rehabilitation therapies like physiotherapy, occupational therapy, speech therapy, and neuropsychological assessments. Participants will be assessed using various tests and scales, including the Action Research Arm Test (ARAT) at 90 days post-stroke as the primary outcome. Additional evaluations include the NIH Stroke Scale, Modified Rankin Score, Extended Barthel Index, De Morton Mobility Index, and Montreal Cognitive Assessment at discharge and 90 days. The study monitors safety and treatment effects over this period, with participant involvement including clinical assessments and rehabilitation according to their needs.

CONDITIONS

Brief Title

Cerebrolysin in Early Stroke Rehabilitation - Tertiary Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to perform the Action Research Arm Test (ARAT)
  • Signed informed consent
  • Both males and females of any age
  • Acute ischemic stroke confirmed by imaging
  • NIHSS score between 6 and 12 indicating moderate to severe neurological impairment
  • No prior stroke or disability (mRS score 0 before stroke)
Not Eligible

You will not qualify if you...

  • Unable to perform the Action Research Arm Test (ARAT)
  • Previous stroke or existing disability (mRS score greater than 0)
  • Unable to understand instructions

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 10 days

Participants receive Cerebrolysin treatment as an adjunct to standard care or standard treatment alone for acute ischemic stroke. Cerebrolysin is given by intravenous infusion daily for 10 consecutive days in the experimental group, while all participants receive standard neurorehabilitation and stroke care according to local guidelines.

Daily visits for 10 days (in-person)

Follow-up

Duration - Approximately 3 months

Participants are assessed for neurological and functional outcomes at discharge and approximately 90 days after stroke to evaluate recovery and safety.

2 visits (at discharge and 90 days post-stroke, in-person)

Trial Site Locations

Total: 1 location

1

UMC Ljubljana - Department of Vascular Neurology and Intensive Neurological Therapy (KOVNINT)

Ljubljana, Slovenia, 1000

Actively Recruiting

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Research Team

M

Matija Zupan, MD, PhD

M

Marjan Zaletel, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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