Epilepsy
Conditions
Keywords
acupuncture, RNS, seizure
Brief summary
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
Interventions
DEVICEAcupuncture intervention
Participants will undergo 12 weeks of acupuncture therapy. There will be one 40 minute-1 hour. session per week.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in number of disabling clinical seizures | Baseline,12 weeks post treatment | This will be measured by self reporting journals |
| Changes in seizure severity | Baseline,12 weeks post treatment | This will be measured by self reporting journals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cognition and mood as assessed by the Quality Of Life In Epilepsy (QOLIE-10) questionnaire | Baseline,12 weeks post treatment | 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) | Baseline,12 weeks post treatment | 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 | Baseline,12 weeks post treatment | 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) | Baseline | — |
Countries
United States
Contacts
Primary ContactOlga Rodziyevska, MS,PA-C
Backup ContactArdonia N Tousant
Outcome results
None listed