Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture intervention | Device | Participants will undergo 12 weeks of acupuncture therapy. There will be one 40 minute-1 hour. session per week. |
|
| 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 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olga Rodziyevska, MS,PA-C | Contact | (713) 500-5482 | Olga.Rodziyevska@uth.tmc.edu | |
| Ardonia N Tousant | Contact | (713) 500-5482 | Ardonia.N.Tousant@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Olga Rodziyevska, MS,PA-C | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |