1. Results of a Randomized Clinical Trial of Speech after Early Neurostimulation in Parkinson's Disease
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Pinto, Serge, Nebel, Adelheid, Rau, Jorn, Espesser, Robert, Maillochon, Pauline, Niebuhr, Oliver, Krack, Paul, Witjas, Tatiana, Ghio, Alain, Cuartero, Marie-Charlotte, Timmermann, Lars, Schnitzler, Alfons, Hesekamp, Helke, Meier, Niklaus, Muellner, Julia, Haelbig, Thomas D., Moeller, Bettina, Paschen, Steffen, Paschen, Laura, Volkmann, Jens, Barbe, Michael T., Fink, Gereon R., Becker, Johannes, Reker, Paul, Kuehn, Andrea A., Schneider, Gerd-Helge, Fraix, Valerie, Seigneuret, Eric, Kistner, Andrea, Rascol, Olivier, Brefel-Courbon, Christine, Ory-Magne, Fabienne, Hartmann, Christian J., Wojtecki, Lars, Fradet, Anne, Maltete, David, Damier, Philippe, Le Dily, Severine, Sixel-Doering, Friederike, Benecke, Petra, Weiss, Daniel, Waechter, Tobias, Pinsker, Marcus O., Regis, Jean, Thobois, Stephane, Polo, Gustavo, Houeto, Jean-Luc, Hartmann, Andreas, Knudsen, Karina, Vidailhet, Marie, Schuepbach, Michael, Deuschl, Gunther, Pinto, Serge, Nebel, Adelheid, Rau, Jorn, Espesser, Robert, Maillochon, Pauline, Niebuhr, Oliver, Krack, Paul, Witjas, Tatiana, Ghio, Alain, Cuartero, Marie-Charlotte, Timmermann, Lars, Schnitzler, Alfons, Hesekamp, Helke, Meier, Niklaus, Muellner, Julia, Haelbig, Thomas D., Moeller, Bettina, Paschen, Steffen, Paschen, Laura, Volkmann, Jens, Barbe, Michael T., Fink, Gereon R., Becker, Johannes, Reker, Paul, Kuehn, Andrea A., Schneider, Gerd-Helge, Fraix, Valerie, Seigneuret, Eric, Kistner, Andrea, Rascol, Olivier, Brefel-Courbon, Christine, Ory-Magne, Fabienne, Hartmann, Christian J., Wojtecki, Lars, Fradet, Anne, Maltete, David, Damier, Philippe, Le Dily, Severine, Sixel-Doering, Friederike, Benecke, Petra, Weiss, Daniel, Waechter, Tobias, Pinsker, Marcus O., Regis, Jean, Thobois, Stephane, Polo, Gustavo, Houeto, Jean-Luc, Hartmann, Andreas, Knudsen, Karina, Vidailhet, Marie, Schuepbach, Michael, and Deuschl, Gunther
- Abstract
BackgroundThe 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. ObjectiveThis 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. MethodsSTN-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. ResultsOver 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. ConclusionAt 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. (c) 2022 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.