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

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

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.

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.

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