Effects of Acupuncture on Patients with Epilepsy Using RNS
Clinical and Electrographic Changes in RNS System Patients with Acupuncture Treatment
This study is testing whether acupuncture can help improve mood, thinking, and reduce seizures in people with epilepsy who have a Responsive Neurostimulation system.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 15 Years to 60 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04677751 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of acupuncture treatment on patients with epilepsy who have been implanted with a Responsive Neurostimulation (RNS) system. It aims to evaluate changes in mood, cognition, and seizure frequency and severity, as well as analyze electrographic activity recorded by the RNS system over a 12-week period. Participants will maintain stable medication and stimulation settings while undergoing acupuncture sessions. The study will also require participants to keep a seizure diary to track their progress.
Who should consider this trial
Good fit: Ideal candidates are patients with epilepsy who have an RNS system implanted and can commit to 12 weeks of acupuncture treatment.
Not a fit: Patients who are unable to provide informed consent, have a bleeding disorder, or are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a complementary treatment option for epilepsy patients, potentially improving their mood and reducing seizure activity.
How similar studies have performed: While acupuncture has been explored in various contexts, this specific approach combining acupuncture with RNS technology is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Olga Rodziyevska, MS,PA-C — The University of Texas Health Science Center, Houston
- Study coordinator: Olga Rodziyevska, MS,PA-C
- Email: Olga.Rodziyevska@uth.tmc.edu
- Phone: (713) 500-5482
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.