Clinical and Electrographic Changes in Responsive Neurostimulation System (RNS) Patients With Acupuncture Treatment

Study Overview
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Brief Summary
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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

Official Title
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Clinical and Electrographic Changes in RNS System Patients With Acupuncture Treatment

Conditions
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Epilepsy

Intervention / Treatment
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* Device: Acupuncture intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Patient or/and caregiver is able to understand and sign informed consent and HIPAA authorization Patient or caregiver able to maintain a seizure diary for duration of study Exclusion Criteria: Patient and /or caregiver is unable to sign informed consent to study Patient has a bleeding disorder, pacemaker, or pregnant

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Device: Acupuncture intervention<br>* Participants will undergo 12 weeks of acupuncture therapy. There will be one 40 minute-1 hour. session per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in number of disabling clinical seizures | This will be measured by self reporting journals | Baseline,12 weeks post treatment | 
| Changes in seizure severity | This will be measured by self reporting journals | Baseline,12 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline,12 weeks post treatment | 
| 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). | Baseline,12 weeks post treatment | 
| 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) | Baseline,12 weeks post treatment | 
| Average number of detections of seizures per-day (as stored by the RNS System) |  | Baseline | 
| Average number of detections of seizures per-day (as stored by the RNS System) |  | end of 1 month | 
| Average number of detections of seizures per-day (as stored by the RNS System) |  | end of 2 months | 
| Average number of detections of seizures per-day (as stored by the RNS System) |  | end of 3 months | 
| Average number of detections of seizures per-day (as stored by the RNS System) |  | 1 month after last treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RNS, acupuncture, seizure