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Adaptive deep brain stimulation as advanced Parkinson’s disease treatment (ADAPT study): protocol for a pseudo-randomised clinical study
  1. Dan Piña-Fuentes1,
  2. Martijn Beudel2,3,
  3. Simon Little4,
  4. Peter Brown5,6,
  5. D L Marinus Oterdoom1,
  6. J Marc C van Dijk1
  1. 1 Department of Neurosurgery, University Medical Centre Groningen, Groningen, The Netherlands
  2. 2 Department of Neurology, University Medical Centre Groningen, Groningen, The Netherlands
  3. 3 Department of Neurology, Amsterdam University Medical Centre, The Netherlands
  4. 4 Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, Queen Square, London, UK
  5. 5 Medical Research Council Brain Network Dynamics Unit, University of Oxford, Oxford, UK
  6. 6 Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom
  1. Correspondence to Mr. Dan Piña-Fuentes; d.a.i.pina.fuentes{at}umcg.nl, dr.danfuentes{at}gmail.com

Abstract

Introduction Adaptive deep brain stimulation (aDBS), based on the detection of increased beta oscillations in the subthalamic nucleus (STN), has been assessed in patients with Parkinson’s disease (PD) during the immediate postoperative setting. In these studies, aDBS was shown to be at least as effective as conventional DBS (cDBS), while stimulation time and side effects were reduced. However, the effect of aDBS on motor symptoms and stimulation-induced side effects during the chronically implanted phase (after the stun effect of DBS placement has disappeared) has not yet been determined.

Methods and analysis This protocol describes a single-centre clinical study in which aDBS will be tested in 12 patients with PD undergoing battery replacement, with electrodes implanted in the STN, and as a proof of concept in the internal globus pallidus. Patients included will be allocated in a pseudo-randomised fashion to a three-condition (no stimulation/cDBS/ aDBS), cross-over design. A battery of tests will be conducted and recorded during each condition, which aim to measure the severity of motor symptoms and side effects. These tests include a tablet-based tapping test, a subscale of the Movement Disorder Society-unified Parkinson’s disease rating scale (subMDS-UPDRS), the Speech Intelligibility Test (SIT) and a tablet-based version of the Stroop test. SubMDS-UPDRS and SIT recordings will be blindly assessed by independent raters. Data will be analysed using a linear mixed-effects model.

Ethics and dissemination This protocol was approved by the Ethical Committee of the University Medical Centre Groningen, where the study will be carried out. Data management and compliance to research policies and standards of our centre, including data privacy, storage and veracity, will be controlled by an independent monitor. All the scientific findings derived from this protocol are aimed to be made public through publication of articles in international journals.

Trial registration number NTR 5456; Pre-results.

  • beta oscillations
  • subthalamic nucleus
  • internal globus pallidus
  • parkinson’s disease
  • adaptive deep brain stimulation
  • local fieldpotentials
  • closed-loop

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Contributors MB and JMCvD designed and prepared the first draft of the protocol, and initiated the study. DP-F formatted the protocol according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines and prepared the manuscript. SL, PB and DLMO critically reviewed the protocol procedures and manuscript. All authors reviewed and approved the final version of this manuscript.

  • Funding This study is publicly funded by grants received from the Dutch Brain Foundation (‘Hersenstichting Nederland’, grant F2015(1)-04), the National Mexican Council of Science and Technology (CONACYT) grant number CVU 652927 and the University of Groningen/University Medical Centre Groningen (RuG/UMCG). SL is personally supported by a Wellcome trust postdoctoral clinical research training grant (105804/Z/14/Z).

  • Disclaimer All the scientific findings derived from this protocol are aimed to be made public through publication of articles in international journals.

  • Competing interests None declared.

  • Ethics approval This protocol is approved by the local ethics committee of our institution, and all procedures are carried out according to the Declaration of Helsinki and the Dutch legislation on medical research involving human subjects.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Not required.

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