47
Programming and stimulation mode data were collected at follow-up visits including unscheduled
programming visits. The following table shows a summary of the burst stimulation settings through
24 weeks. The 100 randomized subjects underwent 350 programming sessions, and the
programmed parameters were within the ranges recommended in the protocol (pulse width of
1000 µs, burst rate of 40 Hz, intra-burst frequency of 500 Hz, and burst train of 5 pulses).
Table 26. Summary of burst stimulation settings for all randomized subjects (N=100)
Number of
Programming
Sessions
Burst Rate
Intra-Burst Rate
Burst Train
40 Hz
20 Hz
500 Hz
5 pulses
Missing
351
350 (99.7%)
1 (0.3%)
351 (100.0%)
350
(99.7%)
1 (0.3%)
Pulse Width
(µs)
Amplitude
Minimum
Target
Maximum
Mean±SD (N)
994.8±68.6
(348)
0.5±0.6 (343)
1.6±1.0 (347)
2.7±0.8 (346)
Minimum
0
0
0
1
Maximum
1000
2
5
5
Recharging data were collected at follow-up visits including unscheduled programming visits. The
following table shows a summary of recharging information through 24 weeks. Recharging
instructions for routine care of a typical neurostimulation system (using tonic stimulation) were
given at the discretion of the investigator; thus, no differences in recharging for tonic and burst
stimulation were expected.
Table 27. Summary of IPG recharging for all available subjects
IPG Recharging
Burst
Tonic
Week 6
Recharged
Yes
51/52 (98.08%)
44/45 (97.78%)
Frequency
Daily
4/51 (7.84%)
3/44 (6.82%)
2–3 times a week
15/51 (29.4%)
13/44 (29.5%)
Weekly
28/51 (54.9%)
23/44 (52.3%)
Every other week
3/51 (5.88%)
3/44 (6.82%)
Once a month or less often
1/51 (1.96%)
2/44 (4.55%)
Reason
Battery heats up
1/51 (1.96%)
0/44 (0.0%)
Low battery message
3/51 (5.88%)
5/44 (11.4%)
Normal routine
43/51 (84.3%)
39/44 (88.6%)
Recommended time frame
4/51 (7.84%)
0/44 (0.0%)