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Enhancement of STroke REhabilitation with Levodopa (ESTREL): Rationale and design of a randomized placebo-controlled, double blind superiority trial.
Zietz, Annaelle; Kaufmann, Josefin E; Wiesner, Karin; Fischer, Sandro Kevin; Wiegert, Martina; Verhagen-Kamerbeek, Wilma Dj; Rottenberger, Yannik; Schwarz, Anne; Peters, Nils; Gensicke, Henrik; Medlin, Friedrich; Möller, Jens Carsten; Bujan, Bartosz; Bonati, Leo H; Arnold, Marcel; Schaedelin, Sabine; Müri, René M; Hemkens, Lars G; Michel, Patrik; Lyrer, Philippe A; Held, Jeremia P; Ford, Gary A; Luft, Andreas R; Traenka, Christopher; Engelter, Stefan T.
Afiliación
  • Zietz A; Neurology and Neurorehabilitation, University Department of Geriatric Medicine FELIX PLATTER, University of Basel, Basel, Switzerland.
  • Kaufmann JE; Department of Neurology and Stroke Center, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Wiesner K; Neurology and Neurorehabilitation, University Department of Geriatric Medicine FELIX PLATTER, University of Basel, Basel, Switzerland.
  • Fischer SK; Department of Neurology and Stroke Center, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Wiegert M; Neurology and Neurorehabilitation, University Department of Geriatric Medicine FELIX PLATTER, University of Basel, Basel, Switzerland.
  • Verhagen-Kamerbeek WD; Department of Neurology and Stroke Center, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Rottenberger Y; Neurology and Neurorehabilitation, University Department of Geriatric Medicine FELIX PLATTER, University of Basel, Basel, Switzerland.
  • Schwarz A; Department of Neurology and Stroke Center, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Peters N; Neurology and Neurorehabilitation, University Department of Geriatric Medicine FELIX PLATTER, University of Basel, Basel, Switzerland.
  • Gensicke H; Department of Neurology and Stroke Center, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Medlin F; Neurology and Neurorehabilitation, University Department of Geriatric Medicine FELIX PLATTER, University of Basel, Basel, Switzerland.
  • Möller JC; Department of Neurology and Stroke Center, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Bujan B; Department of Neurology, University and University Hospital of Zurich, Zurich, Switzerland.
  • Bonati LH; Department of Neurology, University and University Hospital of Zurich, Zurich, Switzerland.
  • Arnold M; Neurology and Neurorehabilitation, University Department of Geriatric Medicine FELIX PLATTER, University of Basel, Basel, Switzerland.
  • Schaedelin S; Department of Neurology and Stroke Center, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Müri RM; Stroke Center, Klinik Hirslanden, Zürich, Switzerland.
  • Hemkens LG; Neurology and Neurorehabilitation, University Department of Geriatric Medicine FELIX PLATTER, University of Basel, Basel, Switzerland.
  • Michel P; Department of Neurology and Stroke Center, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Lyrer PA; Stroke Unit, Cantonal Hospital Fribourg, Fribourg, Switzerland.
  • Held JP; Center for Neurological Rehabilitation, Zihlschlacht, Switzerland.
  • Ford GA; Neurorehabilitation, Klinik Lengg Zürich, Zurich, Switzerland.
  • Luft AR; Department of Neurology and Stroke Center, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
  • Traenka C; Research Department, Rheinfelden Rehabilitation Clinic, Switzerland.
  • Engelter ST; Department of Neurology, University Hospital Inselspital, Bern, Switzerland.
Eur Stroke J ; : 23969873241255867, 2024 Jun 09.
Article en En | MEDLINE | ID: mdl-38853524
ABSTRACT
RATIONALE 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. AIM AND

HYPOTHESIS:

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.

DESIGN:

ESTREL (Enhancement of Stroke REhabilitation with Levodopa) is a randomized (ratio 11), multicenter, placebo-controlled, double-blind, parallel-group superiority trial.

PARTICIPANTS:

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. INTERVENTION 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. COMPARISON Matching placebo plus standardized rehabilitation.

OUTCOMES:

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.

CONCLUSION:

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.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Idioma: En Revista: Eur Stroke J Año: 2024 Tipo del documento: Article País de afiliación: Suiza
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Idioma: En Revista: Eur Stroke J Año: 2024 Tipo del documento: Article País de afiliación: Suiza