Clinical Study

Randomized, Placebo-Controlled, Double-Blind Pilot Study of D-Cycloserine in Chronic Stroke

Table 1

Characteristics and baseline assessment of study participants as a whole and by group (note that mean DETECT -scores were computed for and for DCS + RAP and placebo + RAP groups, resp., due to missing values resulting from technical issues with the instrument). Hx: history; Tx: therapy; SIS: Stroke Impact Scale; TPA: tissue plasminogen activator.

TotalD-Cycloserine + RAP Placebo + RAP
()()()

Age [mean (SD)]55.8 (13.1)57.7 (7.3)53.7 (18.4)0.608
Men/women3/100/73/30.033
Caucasian/African American3/101/62/40.459
Marital status [married/divorced/widowed/other]6/2/1/44/0/1/22/2/0/20.814
Years of education completed13.6 (4.0)14.1 (2.1)13.0 (5.6)0.626
Days after stroke [mean (SD)]391.2 (252.1)456.6 (253.9)315 (249.5)0.334
Smoking Hx, >10 pack-years [yes, no]1/121/51/60.915
Received TPA [yes, no]4/93/41/50.349
Neurointerventional Tx [yes, no]1/120/71/50.363
Baseline performance measures
 MMSE [mean score (SD)]29.2 (1.1)29.3 (0.8)29.0 (1.5)0.673
 A-prime (SD)0.9 (0.05)0.9 (0.0)0.9 (0.0)0.085
 Reaction time [sec (SD)]1248.1 (700.9)1147.8 (644.5)1365.2 (806.2)0.599
 DETECT [mean -score (SD)]10.1 (0.1)10.2 (0.0)10.1 (0.1)0.393
 Grip strength, affected hand [newtons (SD)]4.8 (3.5)4.0 (3.0)5.7 (4.0)0.390
 Grip strength, unaffected hand [newtons (SD)]28.6 (8.4)23.6 (6.6)34.5 (5.9)0.011
 BBT, affected hand [blocks moved (SD)]9.7 (6.9)9.7 (7.9)9.6 (6.2)0.991
 BBT, unaffected hand [blocks moved (SD)]45.9 (9.9)48.7 (12.5)42.7 (4.7)0.289
 CES-D [mean scale score, Day 1/mean (SD)]12.3 (7.9)15.1 (6.5)9.2 (8.8)0.185
 SIS sections [scaled score (SD, FDR reported)]
  Strength51.0 (14.4)50.1 (13.2)51.0 (17.0)0.986
  Memory77.7 (18.3)72.9 (19.7)83.3 (16.5)0.330
  Mood77.4 (15.4)72.6 (16.3)82.9 (13.5)0.248
  Communication89.3 (16.8)85.7 (22.3)93.5 (6.2)0.430
  ADL/IADL78.2 (17.2)78.2 (19.9)78.2 (15.2)0.995
  Mobility70.0 (19.2)64.6 (23.9)76.3 (10.6)0.297
  Hand function26.2 (21.2)24.2 (29.6)28.3 (4.1)0.733
  Social participation62.7 (19.5)53.6 (17.8)73.4 (16.7)0.064
  Percent recovery53.5 (9.9)50.7 (9.3)56.7 (10.3)0.298
Previous diagnoses
 Hypertension [yes, no]10/36/14/20.459
 High cholesterol [yes, no]7/64/33/30.817
 Diabetes mellitus [yes, no]3/101/62/40.459
 Atrial fibrillation [yes, no]0/130/70/6
 Coronary artery disease [yes, no]1/121/60/60.356
 Prior stroke [yes, no]1/121/60/60.356
 Alcoholism [yes, no]1/121/60/60.356
 Substance abuse disorder [yes, no]0/130/70/6
Medications
 Hypertension [yes, no]8/56/12/40.059
 High cholesterol [yes, no]6/74/32/40.433
 Diabetes mellitus [yes, no]3/101/62/40.459
 Anticoagulant [yes, no]6/75/21/50.053