About this trial
The purpose of this study is to determine effects of Acupuncture on a Patient's mood and cognition,evaluate changes in clinically-reported seizure frequency and severity and analyze effects of Acupuncture on electrographic epileptiform activity stored by the RNS System
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient implanted with the RNS system
Patient can undergo 12 weeks of acupuncture
Patient is able remain on stable medications for 12 weeks
Patient is able to remain on stable Detection and Stimulation settings for 12 weeks
Disqualifiers
Patient and /or caregiver is unable to sign informed consent to study
Patient has a bleeding disorder, pacemaker, or pregnant
Trial design
Single group
Treatments tested in this trial
Acupuncture intervention
DeviceParticipants will undergo 12 weeks of acupuncture therapy. There will be one 40 minute-1 hour. session per week.
Treatment groups
Trial outcomes
Primary outcomes
Percent change in number of disabling clinical seizures
This will be measured by self reporting journals
Changes in seizure severity
This will be measured by self reporting journals
Secondary outcomes
Change in cognition and mood as assessed by the Quality Of Life In Epilepsy (QOLIE-10) questionnaire
This is a 10 item questionnaire. Score ranges from 1-6,a higher number indicating a worse outcome.
Change in cognition and mood as assessed by the Patient Health Questionnaire (PHQ-9)
PHQ-9 score can range from 0 to 27,each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day).
Change in cognition and mood as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale
This is a 7 item questionnaire. Each question is scored form 0(not at alll) to 3(nearly every day)
Average number of detections of seizures per-day (as stored by the RNS System)
Sponsors and contacts
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