This Article Full Text (PDF) All Versions of this Article: 1545968308317532v1 23/1/32    most recent References Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Harvey, R. L. Search for Related Content PubMed PubMed Citation Articles by Harvey, R. L. Pubmed/NCBI databases Medline Plus Health Information Arm Injuries and Disorders Clinical Trials Stroke Social Bookmarking                         What's this?

Design for the Everest Randomized Trial of Cortical Stimulation and Rehabilitation for Arm Function Following Stroke

Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University, and the Rehabilitation Institute of Chicago, Chicago, Illinois, rharvey{at}ric.org

Carolee J. Winstein, PhD, PT

Division of Biokinesiology and Physical Therapy, School of Dentistry, Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles, California

for the Everest Trial Group

Background. Cortical stimulation (CS) combined with rehabilitation may improve upper limb motor function after stroke. Objective. Describe the study design for the Everest Clinical Trial, a randomized single-blinded pivotal device trial, testing safety and efficacy of epidural CS delivered during rehabilitation for upper limb motor function in patients with ischemic stroke. Method . A total of 174 participants from 21 centers with hemiplegia at least 4 months after acute ischemic stroke are randomized in a 2:1 ratio to investigational or control groups. Investigational patients undergo implantation of cortical electrode and pulse generator and receive 6 weeks of upper limb rehabilitation with subthreshold CS delivered only during therapy. Control group patients receive the same therapy without device implantation or stimulation. Primary outcome measures include the upper extremity Fugl-Meyer (UEFM) score and the arm motor ability test (AMAT) measured at baseline and 1, 4, 12, and 24 weeks following rehabilitation treatment with primary endpoint at 4 weeks following treatment. A successful outcome is defined as an improvement in UEFM of at least 4.5 points and in AMAT of at least 0.21 points from baseline to primary endpoint. A 20% better success rate between investigational and control groups will be considered clinically meaningful. Adverse events occurring during the study will be identified. Results. Not applicable. Conclusions . The Everest Clinical Trial is the first randomized pivotal trial on the safety and efficacy of direct CS delivered during rehabilitation for recovery of upper limb motor function in patients with ischemic stroke.

Key Words: Hemiplegia • Cortical stimulation • Motor recovery

This version was published on January 1, 2009

Neurorehabilitation and Neural Repair, Vol. 23, No. 1, 32-44 (2009)
DOI: 10.1177/1545968308317532


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				D. A. Nowak, C. Grefkes, M. Ameli, and G. R. Fink Interhemispheric Competition After Stroke: Brain Stimulation to Enhance Recovery of Function of the Affected Hand Neurorehabil Neural Repair, September 1, 2009; 23(7): 641 - 656. [Abstract] [PDF]

				J. H. Cauraugh and J. J. Summers Invited Commentary Physical Therapy, June 1, 2009; 89(6): 539 - 541. [Full Text] [PDF]