Trials / Completed
CompletedNCT02385526
Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation
ASCEND: Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 67 (actual)
- Sponsor
- Cyberonics, Inc. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
Post-market, on-label, double-blind, randomized, prospective, interventional, tolerability and clinical outcomes study to determine the number of patients achieving their final assigned VNS Therapy dose settings in patients with drug-resistant epilepsy who are being treated with adjunctive VNS Therapy using new titration protocols.
Detailed description
Post-market, on-label, double-blind, randomized, prospective, interventional, tolerability and clinical outcomes study is designed to determine which VNS Therapy titration paradigm allows more patients to achieve a therapeutic dose within a specified time frame. Additionally, the study will collect data on the acute tolerability and clinical outcomes for patients with drug-resistant epilepsy treated with adjunctive VNS Therapy employing three different titration paradigms.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vagus Nerve Stimulation Therapy | Stimulation of the left tenth cranial nerve via VNS Therapy |
Timeline
- Start date
- 2015-04-28
- Primary completion
- 2016-10-10
- Completion
- 2016-10-10
- First posted
- 2015-03-11
- Last updated
- 2018-07-23
- Results posted
- 2018-07-23
Locations
15 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02385526. Inclusion in this directory is not an endorsement.