A Post-Market, Open Observational Long-term Effectiveness Follow-up Study of Participants with Drug-resistant Epilepsy with Partial-onset Seizures previously Enrolled in a Randomized Controlled Trial (E-100: PuLsE) Comparing Best Medical Practice with or without Adjunctive Vagus Nerve Stimulation Therapy.
Recruiting
- Conditions
- refractory epilepsy, Vagus Nerve Stimulation, VNS, NVS, Nervus Vagus Stimulatie, refractaire epilepsie
- Registration Number
- NL-OMON26412
- Lead Sponsor
- Cyberonics Inc100 Cyberonics BlvdHouston, Texas 77058USA
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 121
Inclusion Criteria
To be eligible for the study, the participant must meet all the following criteria:
1. Participant must have been randomized in the original PuLsE study;
Exclusion Criteria
The presence of any of the following will exclude a participant from the study:
1. Participant has a history of non-compliance with the completion of a seizure diary;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The objective of this post-market study is to perform exploratory evaluations to identify clinically and statistically significant predictors of response at all follow-up visits in participants with drug-resistant epilepsy with partial-onset seizures treated with Best Medical Practice with or without adjunctive VNS Therapy. This will be accomplished through regression modeling of the response variates (including change in baseline quality of life score and percent reduction in seizure frequency). Predictors will include, but will not be limited to:<br /><br>1. General demographics: age, gender, ethnicity;<br /><br>2. Disease-specific demographics such as etiology, age at onset, seizure type;<br /><br>3. Treatment group (Best Medical Practice without VNS Therapy or Best Medical Practice with adjunctive VNS Therapy);<br /><br>4. Baseline values of health outcomes (quality of life, seizure frequency, comorbid depression, and adverse event profile).
- Secondary Outcome Measures
Name Time Method