The case for modality-specific outcome measures in clinical trials of stroke recovery-promoting agents

被引:86
作者
Cramer, Steven C.
Koroshetz, Walter J.
Finklestein, Seth P.
机构
[1] Biotrofix Inc, Needham, MA 02494 USA
[2] Univ Calif Irvine, Dept Neurol, Irvine, CA 92717 USA
[3] Univ Calif Irvine, Dept Anat & Neurobiol, Irvine, CA 92717 USA
[4] Massachusetts Gen Hosp, Dept Neurol, Boston, MA 02114 USA
[5] Harvard Univ, Sch Med, Boston, MA 02115 USA
关键词
clinical trials; outcome measures; stroke recovery;
D O I
10.1161/01.STR.0000260087.67462.80
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Clinical trials for acute stroke treatments have often used composite clinical rating scales as primary outcome measures of treatment efficacy. Recent preclinical and clinical studies highlight the opportunity to administer treatments in the subacute and chronic phase of stroke to promote neurological recovery. Because different neurological deficits recover to different extents at different rates after stroke, putative stroke recovery-promoting treatments may exert differential effects on various functional aspects of stroke recovery. For this reason, we propose that the use of modality-specific outcome measures may be best suited as primary end points in clinical trials of stroke recovery-promoting agents. The use of such end points may result in a more selective labeling of stroke recovery treatments.
引用
收藏
页码:1393 / 1395
页数:3
相关论文
共 39 条
[1]   Autologous mesenchymal stem cell transplantation in stroke patients [J].
Bang, OY ;
Lee, JS ;
Lee, PH ;
Lee, G .
ANNALS OF NEUROLOGY, 2005, 57 (06) :874-882
[2]  
Brown JA, 2006, NEUROSURGERY, V58, P464, DOI 10.1227/01.NEU.0000197100.63931.04
[3]   Cellular and molecular mechanisms of neural repair after stroke: Making waves [J].
Carmichael, ST .
ANNALS OF NEUROLOGY, 2006, 59 (05) :735-742
[4]   Intravenous bone marrow stromal cell therapy reduces apoptosis and promotes endogenous cell proliferation after stroke in female rat [J].
Chen, JL ;
Li, Y ;
Katakowski, M ;
Chen, XG ;
Wang, L ;
Lu, DY ;
Lu, M ;
Gautam, SC ;
Chopp, M .
JOURNAL OF NEUROSCIENCE RESEARCH, 2003, 73 (06) :778-786
[5]   Improved understanding of cortical injury by incorporating measures of functional anatomy [J].
Crafton, KR ;
Mark, AN ;
Cramer, SC .
BRAIN, 2003, 126 :1650-1659
[6]   A functional MRI study of subjects recovered from hemiparetic stroke [J].
Cramer, SC ;
Nelles, G ;
Benson, RR ;
Kaplan, JD ;
Parker, RA ;
Kwong, KK ;
Kennedy, DN ;
Finklestein, SP ;
Rosen, BR .
STROKE, 1997, 28 (12) :2518-2527
[7]   Effects of fluoxetine and maprotiline on functional recovery in poststroke hemiplegic patients undergoing rehabilitation therapy [J].
Dam, M ;
Tonin, P ;
DeBoni, A ;
Pizzolato, G ;
Casson, S ;
Ermani, M ;
Freo, U ;
Piron, L ;
Battistin, L .
STROKE, 1996, 27 (07) :1211-1214
[8]   Extensive cortical rewiring after brain injury [J].
Dancause, N ;
Barbay, S ;
Frost, SB ;
Plautz, EJ ;
Chen, DF ;
Zoubina, EV ;
Stowe, AM ;
Nudo, RJ .
JOURNAL OF NEUROSCIENCE, 2005, 25 (44) :10167-10179
[9]   Recovery of cognitive function after stroke [J].
Desmond, DW ;
Moroney, JT ;
Sano, M ;
Stern, Y .
STROKE, 1996, 27 (10) :1798-1803
[10]   MEASUREMENT OF MOTOR RECOVERY AFTER STROKE - OUTCOME ASSESSMENT AND SAMPLE-SIZE REQUIREMENTS [J].
DUNCAN, PW ;
GOLDSTEIN, LB ;
MATCHAR, D ;
DIVINE, GW ;
FEUSSNER, J .
STROKE, 1992, 23 (08) :1084-1089