gms | German Medical Science

57th Annual Meeting of the German Society of Neurosurgery
Joint Meeting with the Japanese Neurosurgical Society

German Society of Neurosurgery (DGNC)

11 - 14 May, Essen

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European multi-center study of a new rechargeable neurostimulation system

Europäische Multi-Center-Studie eines neuen wiederaufladbaren Neurostimulationssystems

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  • corresponding author V. Tronnier - Klinik für Neurochirurgie, Universitätsklinikum Schleswig-Holstein, Lübeck
  • J.K. Krauss - Neurochirurgische Universitätsklinik, Hannover
  • D. Rasche - Klinik für Neurochirurgie, Universitätsklinikum Schleswig-Holstein, Lübeck
  • R. Weigel - Neurochirurgische Praxisgemeinschaft im St. Katharinenkrankenhaus, Frankfurt
  • H. Capelle - Neurochirurgische Universitätsklinik, Hannover
  • Y. Lazorthes - CHU Rangueil, Toulouse, France
  • J.P. Van Buyten - Maria Middelares Ziekenhuis, St. Niklaas, Belgium
  • G. Spincemaille - Academisch Ziekenhuis, Maastricht, Netherlands
  • G. Beute - St. Elisabeth Ziekenhuis, Tilburg, Netherlands
  • J.J. Pallarés - Hospital Universitario La Fé, Valencia, Spain
  • F. Zucco - Az. Ospedale, Garbagnate, Italy
  • M. Sindou - Hôpital Neurologique Pierre Werthelmer, Lyon, France
  • J. De Andrés - Hospital General de Valencia, Spain
  • A. Costantini - Ospedale Clinicizzato SS. Annunziata, Chiete, Italy
  • E. Buchser - Hôpital de Zone, Morges, Switzerland

Deutsche Gesellschaft für Neurochirurgie. Japanische Gesellschaft für Neurochirurgie. 57. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie e.V. (DGNC), Joint Meeting mit der Japanischen Gesellschaft für Neurochirurgie. Essen, 11.-14.05.2006. Düsseldorf, Köln: German Medical Science; 2006. DocP 03.39

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/dgnc2006/06dgnc256.shtml

Published: May 8, 2006

© 2006 Tronnier et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

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Objective: A new Rechargeable Neurostimulation System is designed to aid in management of patients with complex chronic pain. It allows physicians to optimize neurostimulation therapy without sacrificing system longevity. To recharge, patients wear an ambulatory recharger with the antenna positioned over the neurostimulator. Recharging is a new, critical responsibility for patients. This study was designed to evaluate patient ability to recharge and to characterize pain outcomes.

Methods: This prospective, open-label study is being conducted in 12 European centers. Baseline measurements were collected after patient informed consent. After implant and wound-healing, recharging was permitted. Ability to recharge was assessed one month post-implant either by measuring a change in battery voltage, or by observing whether the patient could independently perform a recharge session. Up to 2 subsequent visits (for 3 attempts in total) were allowed. The prospective performance criterion was that the 95% lower confidence bound (LCB) of success must be >75%. Outcomes measurements (VAS, pain relief, paresthesia coverage, Oswestry Disability Index and EQ-5D) were collected 3 months post-implant. Follow-up continues to 12 months.

Results: Of 45 enrolled, 42 implanted patients, 41 met prospective analysis criteria. All 41 succeeded at recharging (95% LCB=93.0%). Of these, 40 succeeded upon first attempt. Recharging was rated easy or somewhat easy by 78.6% (14.3% rated it difficult or somewhat difficult). The neurostimulator was surgically repositioned in 1 patient to improve comfort. Comparing baseline to 3 months, the mean VAS score for primary pain area was reduced from 7.2±1.5 to 2.8±1.9 (p<0.0001). EQ-5D (p<0.0001) and Oswestry (p<0.0001) scores were also improved.

Conclusions: All patients successfully used the recharger, and the majority rated the usability easy or somewhat easy after limited experience with the device. Outcomes of pain reduction, quality of life, and functional status were all improved 3 months post-implant.