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Randomized Controlled Trial
. 2023 Feb;38(2):212-222.
doi: 10.1002/mds.29282. Epub 2022 Dec 3.

Results of a Randomized Clinical Trial of Speech After Early Neurostimulation in Parkinson's Disease

Serge Pinto #  1 , Adelheid Nebel #  2 , Jörn Rau #  3 , Robert Espesser #  1 , Pauline Maillochon  1 , Oliver Niebuhr  4 , Paul Krack  5 , Tatiana Witjas  6 , Alain Ghio  1 , Marie-Charlotte Cuartero  1 , Lars Timmermann  7 , Alfons Schnitzler  8 , Helke Hesekamp  9 , Niklaus Meier  9 , Julia Müllner  9 , Thomas D Hälbig  9 , Bettina Möller  2 , Steffen Paschen  2 , Laura Paschen  2 , Jens Volkmann  2 , Michael T Barbe  7 , Gereon R Fink  7 , Johannes Becker  7 , Paul Reker  7 , Andrea A Kühn  10 , Gerd-Helge Schneider  10 , Valérie Fraix  5 , Eric Seigneuret  5 , Andrea Kistner  5 , Olivier Rascol  11 , Christine Brefel-Courbon  11 , Fabienne Ory-Magne  11 , Christian J Hartmann  8 , Lars Wojtecki  8 , Anne Fradet  12 , David Maltête  13 , Philippe Damier  14 , Séverine Le Dily  14 , Friederike Sixel-Döring  15 , Petra Benecke  15 , Daniel Weiss  16 , Tobias Wächter  16 , Marcus O Pinsker  17 , Jean Régis  6 , Stéphane Thobois  18 , Gustavo Polo  18 , Jean-Luc Houeto  12 , Andreas Hartmann  9 , Karina Knudsen  2 , Marie Vidailhet  9 , Michael Schüpbach  9 , Günther Deuschl #  2 ; EARLYSTIM Study Group
Affiliations
Randomized Controlled Trial

Results of a Randomized Clinical Trial of Speech After Early Neurostimulation in Parkinson's Disease

Serge Pinto et al. Mov Disord. 2023 Feb.

Abstract

Background: The EARLYSTIM trial demonstrated for Parkinson's disease patients with early motor complications that deep brain stimulation of the subthalamic nucleus (STN-DBS) and best medical treatment (BMT) was superior to BMT alone.

Objective: This prospective, ancillary study on EARLYSTIM compared changes in blinded speech intelligibility assessment between STN-DBS and BMT over 2 years, and secondary outcomes included non-speech oral movements (maximum phonation time [MPT], oral diadochokinesis), physician- and patient-reported assessments.

Methods: STN-DBS (n = 102) and BMT (n = 99) groups underwent assessments on/off medication at baseline and 24 months (in four conditions: on/off medication, ON/OFF stimulation-for STN-DBS). Words and sentences were randomly presented to blinded listeners, and speech intelligibility rate was measured. Statistical analyses compared changes between the STN-DBS and BMT groups from baseline to 24 months.

Results: Over the 2-year period, changes in speech intelligibility and MPT, as well as patient-reported outcomes, were not different between groups, either off or on medication or OFF or ON stimulation, but most outcomes showed a nonsignificant trend toward worsening in both groups. Change in oral diadochokinesis was significantly different between STN-DBS and BMT groups, on medication and OFF STN-DBS, with patients in the STN-DBS group performing slightly worse than patients under BMT only. A signal for clinical worsening with STN-DBS was found for the individual speech item of the Unified Parkinson's Disease Rating Scale, Part III.

Conclusion: At this early stage of the patients' disease, STN-DBS did not result in a consistent deterioration in blinded speech intelligibility assessment and patient-reported communication, as observed in studies of advanced Parkinson's Disease. © 2022 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Trial registration: ClinicalTrials.gov NCT00354133.

Keywords: Parkinson's disease; deep brain stimulation; dysarthria; speech; subthalamic nucleus.

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References

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