ASCEND: A randomized controlled trial of titration strategies for vagus nerve stimulation in drug-resistant epilepsy Article Swipe
Anto Bagić
,
Ryan Verner
,
Selim R. Benbadis
,
Pegah Afra
,
Anto Bagić
,
Selim R. Benbadis
,
George Nune
,
Toufic Fakhoury
,
S. L. Helmers
,
Daniel Winkel
,
Batool Kirmani
,
Roger Oghlakian
,
Travis Losey
,
David M. Treiman
,
Lawrence P. Bernstein
,
Michael Macken
,
Deepak Madhavan
,
Kalarickal J. Oommen
,
Daniela Minecan
,
Jeffrey C. Way
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1016/j.yebeh.2023.109333
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1016/j.yebeh.2023.109333
Vagus Nerve Stimulation (VNS) therapy is widely understood to provide clinically meaningful improvements in seizure control to patients with drug-resistant epilepsy, and has been a staple in the clinical armamentaria available to epileptologists for over 25 years. Despite the long history of evidence-based reviews by neurology professional societies, there is still evidence of a practice gap in VNS titration and dosing that aims to maximize clinical benefit. Recent retrospective analyses have strongly argued for a more consistent application of a population-wide target dose of VNS, and further argued the importance of quickly achieving this target dose to hasten the onset of clinical benefits; however, these analyses failed to provide evidence for practical implementation. Herein, we describe a randomized controlled trial assessing the impact of titrating VNS according to three different protocols to achieve the target dose of 1.5 mA at 500µsec, for a 20-Hz signal frequency. The study was registered as NCT02385526 on March 11, 2015. Sixty-two patients were randomized into treatment groups that followed different titration protocols. One protocol (Group A) was designed to align with currently accepted professional guidance for VNS titration and the manufacturer's labeling for VNS in epilepsy (Heck et al., 2002), while the other two protocols were derived from VNS applications in other therapeutic areas. Group A participants were most likely to achieve the target dose parameters in 12 weeks or less (81.8%), with a median time-until-achievement of the target dose of 8.1 weeks, while less than 60% of patients in other groups were able to achieve the same endpoint. Participants in all groups experienced low levels of transient tolerability concerns and adverse events, suggesting titration to the target dose in 12 weeks or less following the Group A protocol is generally acceptable to most patients. These findings indicate that patients receiving VNS for epilepsy can achieve the manufacturer-recommended dose range in 12 weeks or less. A wider implementation of the approach will likely improve the clinical impact of VNS on seizure control and prevent undertreatment.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1016/j.yebeh.2023.109333
- http://www.epilepsybehavior.com/article/S1525505023002524/pdf
- OA Status
- hybrid
- Cited By
- 9
- References
- 31
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4383653230
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4383653230Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1016/j.yebeh.2023.109333Digital Object Identifier
- Title
-
ASCEND: A randomized controlled trial of titration strategies for vagus nerve stimulation in drug-resistant epilepsyWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2023Year of publication
- Publication date
-
2023-07-08Full publication date if available
- Authors
-
Anto Bagić, Ryan Verner, Selim R. Benbadis, Pegah Afra, Anto Bagić, Selim R. Benbadis, George Nune, Toufic Fakhoury, S. L. Helmers, Daniel Winkel, Batool Kirmani, Roger Oghlakian, Travis Losey, David M. Treiman, Lawrence P. Bernstein, Michael Macken, Deepak Madhavan, Kalarickal J. Oommen, Daniela Minecan, Jeffrey C. WayList of authors in order
- Landing page
-
https://doi.org/10.1016/j.yebeh.2023.109333Publisher landing page
- PDF URL
-
https://www.epilepsybehavior.com/article/S1525505023002524/pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
hybridOpen access status per OpenAlex
- OA URL
-
https://www.epilepsybehavior.com/article/S1525505023002524/pdfDirect OA link when available
- Concepts
-
Vagus nerve stimulation, Epilepsy, Randomized controlled trial, Medicine, Drug Resistant Epilepsy, Population, Neurology, Clinical trial, Anesthesia, Dosing, Epilepsy surgery, Vagus nerve, Stimulation, Psychiatry, Surgery, Pharmacology, Internal medicine, Environmental healthTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
9Total citation count in OpenAlex
- Citations by year (recent)
-
2025: 5, 2024: 4Per-year citation counts (last 5 years)
- References (count)
-
31Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.epileptologists | 32 |
| abstract_inverted_index.implementation. | 112 |
| abstract_inverted_index.population-wide | 80 |
| abstract_inverted_index.undertreatment. | 330 |
| abstract_inverted_index.time-until-achievement | 231 |
| abstract_inverted_index.manufacturer-recommended | 303 |
| cited_by_percentile_year.max | 98 |
| cited_by_percentile_year.min | 97 |
| corresponding_author_ids | https://openalex.org/A5080485230, https://openalex.org/A5041821444, https://openalex.org/A5003954328, https://openalex.org/A5080485230, https://openalex.org/A5003954328, https://openalex.org/A5005565023 |
| countries_distinct_count | 1 |
| institutions_distinct_count | 20 |
| corresponding_institution_ids | https://openalex.org/I166722992, https://openalex.org/I170201317, https://openalex.org/I223532165, https://openalex.org/I2613432, https://openalex.org/I4210133620 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/3 |
| sustainable_development_goals[0].score | 0.7699999809265137 |
| sustainable_development_goals[0].display_name | Good health and well-being |
| citation_normalized_percentile.value | 0.80821317 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | False |