Tablet Instructions
80
RNS
®
System Programming Manual
Recommended Therapy Modifications After Observing Clinical Response
Once the neurostimulator is programmed to provide responsive stimulation, the patient should be
seen at approximately 3-month intervals to determine whether detection and/or responsive therapy
settings should be modified. At each patient visit, the physician reviews ECoGs that are stored on the
PDMS or programmer. Detection settings should promptly detect ECoG activity and not detect on
baseline activity.
Based on the clinical response, the physician may choose to modify stimulation. If so, it is
recommended that the current amplitude be increased in 0.5 mA increments, and that new settings
be tested (see
Test Stimulation Before Enabling
) to ensure that it is well tolerated by
the patient and there are no undesired changes in the ECoG such as afterdischarges.
•
Review data such as lead impedance, battery voltage, number of detections and stimulations,
and stored ECoGs.
•
Adjust stimulation settings if the patient reports an acute worsening or increase in clinical
seizures that is not typical.
•
Consider making minor adjustments if the patient reports only a mild or no improvement in
clinical seizures.
•
Allow sufficient time between stimulation adjustments to assess the patient’s clinical seizure
response.
In the RNS
®
System Pivotal study very few subjects used any of the additional responsive stimulation
therapy options (see
). These were: pattern specific therapy (each detector triggers a different
stimulation setting); adaptive therapy (the stimulation frequency adjusts with the ECoG frequency);
synchronized stimulation (stimulation is delivered into a specific part of the ECoG waveform); and
post episode interval (responsive therapies are disabled for a specified period of time after detecting
the end of the episode).
provides the number and percentage of subjects who were treated
with any of the additional stimulation therapy options.
Table 1: Additional responsive stimulation therapy options
Number and (%) of
Subjects Programmed
Pattern Specific Therapy
29 (15%)
Adaptive Therapy
4 (2%)
Synchronized Stimulation
3 (2%)
Post-Episode Interval
4 (2%)
Summary of Contents for PDMS 4340
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