Epidural Electrical Stimulation for Stroke Rehabilitation

Robert M. Levy, Richard L. Harvey, Brett M. Kissela, Carolee J. Winstein, Helmi Lutsep, Todd B. Parrish, Steven C. Cramer, Lalit Venkatesan

Research output: Contribution to journalArticle

67 Scopus citations

Abstract

Background. This prospective, single-blinded, multicenter study assessed the safety and efficacy of electrical epidural motor cortex stimulation (EECS) in improving upper limb motor function of ischemic stroke patients with moderate to moderately severe hemiparesis. Methods. Patients ≥4 months poststroke were randomized 2:1 to an investigational (n = 104) or control (n = 60) group, respectively. Investigational patients were implanted (n = 94) with an epidural 6-contact lead perpendicular to the primary motor cortex and a pulse generator. Both groups underwent 6 weeks of rehabilitation, but EECS was delivered to investigational patients during rehabilitation. The primary efficacy endpoint (PE) was defined as attaining a minimum improvement of 4.5 points in the upper extremity Fugl-Meyer (UEFM) scale as well as 0.21 points in the Arm Motor Ability Test (AMAT) 4 weeks postrehabilitation. Follow-up assessments were performed 1, 4, 12, and 24 weeks postrehabilitation. Safety was evaluated by monitoring adverse events (AEs) that occurred between enrollment and the end of rehabilitation. Results. Primary intent-to-treat analysis showed no group differences at 4 weeks, with PE being met by 32% and 29% of investigational and control patients, respectively (P =.36). Repeated-measures secondary analyses revealed no significant treatment group differences in mean UEFM or AMAT scores. However, post hoc comparisons showed that a greater proportion of investigational (39%) than control (15%) patients maintained or achieved PE (P =.003) at 24 weeks postrehabilitation. Investigational group mean AMAT scores also improved significantly (P

Original languageEnglish (US)
Pages (from-to)107-119
Number of pages13
JournalNeurorehabilitation and Neural Repair
Volume30
Issue number2
DOIs
StatePublished - Feb 1 2016

Keywords

  • cortical stimulation
  • hemiparesis
  • rehabilitation
  • stroke

ASJC Scopus subject areas

  • Clinical Neurology
  • Rehabilitation
  • Neurology

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  • Cite this

    Levy, R. M., Harvey, R. L., Kissela, B. M., Winstein, C. J., Lutsep, H., Parrish, T. B., Cramer, S. C., & Venkatesan, L. (2016). Epidural Electrical Stimulation for Stroke Rehabilitation. Neurorehabilitation and Neural Repair, 30(2), 107-119. https://doi.org/10.1177/1545968315575613