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@ARTICLE{Hensel:868434,
      author       = {Hensel, Lukas and Grefkes, Christian and Tscherpel,
                      Caroline and Ringmaier, Corinna and Kraus, Daria and
                      Hamacher, Stefanie and Volz, Lukas J and Fink, Gereon R},
      title        = {{I}ntermittent theta burst stimulation applied during early
                      rehabilitation after stroke: study protocol for a randomised
                      controlled trial},
      journal      = {Open Heart},
      volume       = {9},
      number       = {12},
      issn         = {2044-6055},
      address      = {London},
      publisher    = {BMJ66930},
      reportid     = {FZJ-2020-00029},
      pages        = {e034088 -},
      year         = {2019},
      abstract     = {ntroduction Intermittent theta burst stimulation (iTBS)
                      applied to primary motor cortex (M1) has been shown to
                      modulate both the excitability and connectivity of the motor
                      system. A recent proof-of-principle study, based on a small
                      group of hospitalised patients with acute ischemic stroke,
                      suggested that iTBS applied to the ipsilesional M1 combined
                      with physical therapy early after stroke can amplify motor
                      recovery with lasting after effects. A randomised controlled
                      clinical trial using a double-blind design is warranted to
                      justify the implementation of iTBS-assisted motor
                      rehabilitation in neurorehabilitation from an acute
                      ischaemic stroke.Methods/design We investigate the effects
                      of daily iTBS on early motor rehabilitation after stroke in
                      an investigator-initiated, longitudinal randomised
                      controlled trial. Patients (n=150) with hemiparesis receive
                      either iTBS (600 pulses) applied to the ipsilesional motor
                      cortex (M1) or a control stimulation (ie, coil placement
                      over the parieto-occipital vertex in parallel to the
                      interhemispheric fissure and with a tilt of 45°). On 8
                      consecutive workdays, a 45 min arm-centred motor training
                      follows the intervention . The relative grip strength,
                      defined as the grip force ratios of the affected and
                      unaffected hands, serves as the primary outcome parameter.
                      Secondary outcome parameters are measures of arm function
                      (Action Research Arm Test, Fugl-Meyer Motor Scale), stroke
                      severity (National Institutes of Health Stroke Scale),
                      stroke-induced disability (modified Rankin Scale, Barthel
                      Index), duration of inpatient rehabilitation, quality of
                      life (EuroQol 5D), motor evoked potentials and the resting
                      motor threshold of the ipsilesional M1.Ethics and
                      dissemination The study was approved by the Ethics
                      Commission of the Medical Faculty, University of Cologne,
                      Germany (reference number 15-343). Data will be disseminated
                      through peer-reviewed publications and presentations at
                      conferences. Study title: Theta-Burst Stimulation in Early
                      Rehabilitation after Stroke (acronym: TheSiReS). Study
                      registration at German Registry for Clinical Trials
                      (DRKS00008963) and at ClinicalTrials.gov (NCT02910024).},
      cin          = {INM-3},
      ddc          = {610},
      cid          = {I:(DE-Juel1)INM-3-20090406},
      pnm          = {572 - (Dys-)function and Plasticity (POF3-572)},
      pid          = {G:(DE-HGF)POF3-572},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:31892668},
      UT           = {WOS:000512773400288},
      doi          = {10.1136/bmjopen-2019-034088},
      url          = {https://juser.fz-juelich.de/record/868434},
}