IMPULSE - StIMulation of Brain Plasticity to Improve Upper Limb Recovery After StrokE

What Was Tested

In this phase 2 trial, researchers set out to test Cerebrolysin.

Stroke is a leading cause of adult long-term disability worldwide.

It had two arms (groups): Verum (active comparator) and Control (placebo comparator).

The registry classes the interventions as device and drug.

Who Took Part

The registry lists 4 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 18-80 years of age, both inclusive, of all sexes. 8 weeks to 12 months after a first-ever hemispheric subcortical ischemic stroke, confirmed by imaging. Pre-stroke modified Rankin Scale (mRS) 0 or 1. Action Research Arm Test (ARAT) score 13-50, both inclusive. Patient participates voluntarily and gave written informed consent.

The full record lists 6 inclusion and 23 exclusion criteria; among the exclusions: severe sensory deficits (score of 2 on item 8 of the nihss); severe aphasia (a score of ≥2 on item 9 of the nihss); severe neglect (a score of 2 on item 11 of the nihss).

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Cerebrolysin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Cerebrolysin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-06-25 with completion listed for 2022-03-21.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Action Research Arm Test (ARAT) (time frame: Day 21).

It also tracked 3 secondary outcomes, for example Nine-Hole Peg Test (NHPT), Hand grip dynamometry and National Institutes of Health Stroke Scale (NIHSS).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cerebrolysin in 4 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cerebrolysin compound page, all human trials.