Repetitive transcranial magnetic stimulation with patients with disorders of consciousness: a double blind study protocol

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Repetitive transcranial magnetic stimulation with disorders of consciousness: a sham-controlled

randomized double-blind study protocol

Audrey Wolff1,2_{, Martin Rosenfender}3,4_{, Masachika Niimi}1,_{, Leandro Sanz}1_{,Steven Laureys}1_{, Andreas Bender}3,4_{, Olivia Gosseries}1

1_{GIGA-Consciousness, Coma Science Group, University of Liège, Belgium |}2 _{Faculty of Medicine and Life Sciences,}

Hasselt University, Hasselt, Belgium|3_{Department of Neurology, Therapiezentrum Burgau |}4_{Neurological Clinic and Policlinic, Großhadern Hospital, Ludwig-Maximilian-Universität}

awolff@uliege.be

Introduction

Methods

Few existing treatments for patients with disorders of consciousness (DOC) rTMS = non-invasive method that induces changes in cortical neural excitability

DOC patients1_:

Hypothesis: high frequency rTMS pulses on the left prefrontal cortex will significantly increase neurobehavioral functioning

Coma • No eye opening • Reflex behavior Unresponsive Wakefulness Syndrome (UWS) • Eye opening • Reflex behavior

Minimally Conscious State (MCS)

• Eye opening • Non reflex behavior

Emergence from MCS • Functional communication • Functional use of objects

Examiner A : CRS-R

POPULATION

10 UWS patients and 10 MCS patients

Diagnosis based on 5 Coma Recovery Scale – Revised2_(CRS-R)

Examiner(s) B: rTMS sessions

rTMS Nexstim or Deymed

Left prefrontal cortex

RESTING STATE 256 EGI Geodesics 15 min 2 SESSIONS Minimum 48h apart 1 SHAM 1 REAL MULTICENTRIC STUDY

1. Coma Science Group (Belgium) 2. Therapiezentrum Burgau (Germany)

2

BLIND EXAMINERS

Intensity: 90% rMT, Frequency: 10 Hz3,4 1. Trains of 50 stimulations in 5 s

2. Repeated 20 times with an interval of 20s

= 1000 pulses ≈ 8 min and 20s CRS-R

30 min Bibliography:

1.Bodart, O, et al. Semin Neurology, 2013; 33(2):83-90 2. Giacino, JT. et al. Arch Phys Med Rehabil 2004;85:2020-9 3. Xia, X. et al. Front. Neurol. 2017; 8(182)

4, Naro,A. et al. Neurorehabil and Neural Repair. 2015; 29:603-13

RESTING STATE 256 EGI Geodesics 15 min CRS-R 30 min Neuronavigation based on individual T1