69
Table 47. Summary of PCS scores
Randomization
Arm 1:
tonic/burst
Arm 2:
burst/tonic
Pooled
Burst-Tonic
Mean ± SD (N)
-2.2±10.3 (45)
3.1±11.8 (51)
—
Minimum, Median, Maximum
-24.0, 0.0, 31.0 -22.0, 2.0, 52.0
—
Burst-Tonic Average ± Pooled SD
Across Arms
0.5±5.6
95% CI
-1.8, 2.7
The BDI‡-II was completed at baseline, week 12, and week 24. Higher scores indicate higher
levels of depression symptoms. Subjects with moderate to severe depression symptoms, with a
score of 24 or more at baseline, were not eligible to continue in the study. The mean baseline
score (10.1) indicates the subject population had minimal depression symptoms. The minimal
depression symptoms that were observed at baseline continued to be observed under both
stimulation modes at follow-up. The BDI-II scores may have remained the same because those
subjects with clinically significant depression symptoms were excluded from the study. Further,
an improvement from minimal depression symptoms would not necessarily be expected. The
following table shows a summary of BDI-II scores.
Table 48. Summary of BDI-II scores
Randomization
Arm 1:
tonic/burst
Arm 2:
burst/tonic
Pooled
Baseline
Mean ± SD (N)
10.5±6.6 (45)
9.8±5.5 (51)
10.1±6.0 (96)
Minimum, Median, Maximum
0.0, 9.0, 24.0
0.0, 9.0, 23.0
—
Burst
Mean ± SD (N)
9.0±9.4 (45)
8.9±5.7 (51)
8.9±7.6 (96)
Minimum, Median, Maximum
0.0, 7.0, 50.0
0.0, 9.0, 24.0
—
Tonic
Mean ± SD (N)
9.8±7.6 (45)
9.5±6.5 (51)
9.6±7.0 (96)
Minimum, Median, Maximum
0.0, 9.0, 35.0
0.0, 9.0, 27.0
—
Burst-Tonic
Mean ± SD (N)
-0.8±6.1 (45)
-0.5±5.0 (51)
—
Minimum, Median, Maximum
-12.0, -2.0, 17.0 -18.0, -1.0, 13.0
—
Burst-Tonic Average ± Pooled SD
Across Arms
-0.7±2.8
95% CI
-1.8, 0.4