Time course of motor recovery after stroke with and without levodopa: a post hoc 6-month longitudinal analysis of the ESTREL trial.
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Trüssel Simon, Traenka Christopher K, Polymeris Alexandros, Enz Lukas, Zietz Annaelle, Altersberger Valerian L, Wiesner Karin, Katan Mira, Lyrer Philippe A, Goga Irina, Engelter Sophia, Luft Andreas R, Rottenberger Yannik, Schwarz Anne, Medlin Friedrich, Müri René M, Seiffge David, Fischer Urs, Michel Patrik, Peters Nils, Kägi Georg, Politz Svetlana, Tarnutzer Alexander, Nedeltchev Krassen, Bonati Leo, Schuster-Amft Corina, Möller J Carsten, Bujan Bartosz, Sandor Peter S, Gonzenbach Roman, Mylius Veit, Lienert Carmen, Held Jeremia, Schaedelin Sabine, Hemkens Lars G, Ford Gary A, Kaufmann Josefin E, Gensicke Henrik, Engelter Stefan T
Аннотация
PATIENTS AND METHODS: The ESTREL trial, a double-blind, randomised controlled clinical trial, compared a 39-day regimen of levodopa/carbidopa (100 mg/25 mg, 3×/day) to placebo alongside standardised task-oriented training. We longitudinally analysed Fugl-Meyer Motor Assessment (FMA) total scores (primary outcome), mRS and NIHSS (secondary outcomes) at baseline (0-7 days post stroke), 5 weeks, 3 and 6 months using linear mixed-effects models including timepoint, treatment allocation and their interaction.
RESULTS: In total, 576 of 610 (94%) participants (median age 73 years; 40% female) were analysed. FMA scores improved over time in both groups (P < .001), with no overall levodopa effect across visits (estimate 0.65 points, 95% CI, -3.3 to 4.6; P = .75). There was no indication that levodopa modified the recovery trajectory (χ2 = 0.52, df = 3, P = .91), and estimated levodopa-placebo differences in FMA changes across visit intervals were small, ranging from -0.7 to +0.8 points, with confidence intervals crossing zero. Secondary outcomes showed similar longitudinal improvement, without evidence of a treatment effect.
CONCLUSION: In this post hoc analysis of ESTREL participants with repeated FMA assessments, motor impairment improved from the first days after stroke up to 6 months. Levodopa added to task-oriented inpatient rehabilitation did not improve motor recovery or alter its trajectory over this period.
CLINICAL TRIAL REGISTRATION: NCT03735901, available at ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT03735901?cond=NCT03735901&rank=1.