ESTREL - a study on regeneration after stroke

The Parkinson drug «Levodopa» could improve motor recovery after a stroke. This question is now being tested in a randomized approach.

Considerable progress has been made in recent years in the acute treatment of stroke patients. This includes consistent treatment in certified stroke units and stroke centers as well as the use of acute revascularisation therapies. However, such successes are largely lacking in neurorehabilitation after a stroke. More than two thirds of all stroke patients have long-term motor deficits.

Regardless of a possible reduction of this number through improved acute therapy, a stroke remains the most common cause of disability in adulthood in the western world. Recovery after ischemic brain tissue damage is based on the concept of neuroplasticity with a reorganisation of the damaged neural network. Some of the processes responsible for this can be modulated pharmacologically.

ESTREL

Enhancement of STroke REhabilitation with Levodopa: A randomized controlled trial

Principal Investigator
Prof. Stefan Engelter, Felix Platter Hospital and University Hospital Basel

Study centres
24

Planned patients
610

Duration of the project
2019-2024

DKF support
Methodological Consulting, Statistics, Projekt Management, Data Managament, Data Science, Monitoring

Funding
SNF IICT


Can dopamine help stroke patients with regeneration of their motoric skills?


Background
Preclinical studies show that dopamine plays an important role in synaptic plasticity and motor learning. There are optimistic data on the use of dopaminergic substances in stroke patients. Already in 2001, a randomized double-blind study observed a remarkable improvement in motor recovery with levodopa (compared to placebo) in addition to physiotherapy. However, only 53 people participated in this study and the positive effect of levodopa could not be repeated in later studies.

Objective
This study investigates whether in the case of a stroke, the 5-week administration of levodopa in addition to standardized rehabilitation is associated with a patient-relevant improvement in motor regeneration. To test the sustainability of the intervention, an evaluation is also planned after six and twelve months. The primary measurement tool is the Fugl Meyer Assessment Score, which is considered the gold standard for rehabilitative research on motor issues. Furthermore, so-called PROMS, "Patient-Reported-Outcome-Measures" are used as secondary endpoints. The patients' subjective assessment of their own well-being is thus given high priority.

Study Methodology
Multi-center, randomized, placebo-controlled study

Importance of the study
A positive effect of taking levodopa in the early stages of stroke rehabilitation would be of great importance. Levodopa would provide a beneficial and usually well-tolerated substance known from the treatment of Parkinson's disease to improve motor recovery after a stroke.