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
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
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%)
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