CompletedNot Applicable

PuLsE 2-Observational Long-Term Effectiveness Follow-Up Study of PuLsE 1

Belgium, Canada, France81 participantsStarted 2011-03

Plain-language summary

This is 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 (PuLsE) comparing Best Medical Practice with or without adjunctive Vagus Nerve Stimulation Therapy.

Who can participate

Age range16 Years

SexALL

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Inclusion criteria

✓. Participant must have been randomized in the original PuLsE study.
✓. Participant must have baseline data from the original PuLsE study.
✓. Participant is able to give accurate seizure counts, health outcomes information, and complete study instruments with minimal assistance.
✓. Participant or legal guardian understands study procedures and has voluntarily signed an informed consent for PuLsE 2 in accordance with institutional and local regulatory policies.

Exclusion criteria

✕. Participant has a history of non-compliance with the completion of a seizure diary.
✕. Participant currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
✕. Participant is expected to require full body magnetic resonance imaging during the clinical study.

What they're measuring

Exploratory evaluations

Timeframe: 5 years

Trial details

NCT IDNCT01281280

SponsorCyberonics, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-10

View on ClinicalTrials.gov More Epilepsy trials