Enhancement of STroke REhabilitation with Levodopa (ESTREL): Rationale and design of a randomized placebo-controlled, double blind superiority trial.

Details

Serval ID
serval:BIB_001588389DCA
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Enhancement of STroke REhabilitation with Levodopa (ESTREL): Rationale and design of a randomized placebo-controlled, double blind superiority trial.
Journal
European stroke journal
Author(s)
Zietz A., Kaufmann J.E., Wiesner K., Fischer S.K., Wiegert M., Verhagen-Kamerbeek W.D., Rottenberger Y., Schwarz A., Peters N., Gensicke H., Medlin F., Möller J.C., Bujan B., Bonati L.H., Arnold M., Schaedelin S., Müri R.M., Hemkens L.G., Michel P., Lyrer P.A., Held J.P., Ford G.A., Luft A.R., Traenka C., Engelter S.T.
ISSN
2396-9881 (Electronic)
ISSN-L
2396-9873
Publication state
In Press
Peer-reviewed
Oui
Language
english
Notes
Publication types: Journal Article
Publication Status: aheadofprint
Abstract
Novel therapeutic approaches are needed in stroke recovery. Whether pharmacological therapies are beneficial for enhancing stroke recovery is unclear. Dopamine is a neurotransmitter involved in motor learning, reward, and brain plasticity. Its prodrug levodopa is a promising agent for stroke recovery.
To investigate the hypothesis that levodopa, in addition to standardized rehabilitation therapy based on active task training, results in an enhancement of functional recovery in acute ischemic or hemorrhagic stroke patients compared to placebo.
ESTREL (Enhancement of Stroke REhabilitation with Levodopa) is a randomized (ratio 1:1), multicenter, placebo-controlled, double-blind, parallel-group superiority trial.
610 participants (according to sample size calculation) with a clinically meaningful hemiparesis will be enrolled ⩽7 days after stroke onset. Key eligibility criteria include (i) in-hospital-rehabilitation required, (ii) capability to participate in rehabilitation, (iii) previous independence in daily living.
Levodopa 100 mg/carbidopa 25 mg three times daily, administered for 5 weeks in addition to standardized rehabilitation. The study intervention will be initiated within 7 days after stroke onset.
Matching placebo plus standardized rehabilitation.
The primary outcome is the between-group difference of the Fugl-Meyer-Motor Assessment (FMMA) total score measured 3 months after randomization. Secondary outcomes include patient-reported health and wellbeing (PROMIS 10 and 29), patient-reported assessment of improvement, Rivermead Mobility Index, modified Rankin Scale, National Institutes of Health Stroke Scale (NIHSS), and as measures of harm: mortality, recurrent stroke, and serious adverse events.
The ESTREL trial will provide evidence of whether the use of Levodopa in addition to standardized rehabilitation in stroke patients leads to better functional recovery compared to rehabilitation alone.
Keywords
Fugl-Meyer-motor assessment, levodopa, motor recovery, neurorehabilitation, protocol, randomized controlled trial, stroke rehabilitation
Pubmed
Create date
14/06/2024 11:09
Last modification date
15/06/2024 7:04
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