Evidence map›Paper›PMID 40579354›Full record

ArticleNeurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics2025

Clinical experience implanting a miniature externally powered vagus nerve stimulator.

Joseph D Epperson, Michael L Foreman, Richard C Naftalis, Rita G Hamilton, Mark B Powers, Holle L Gallaway, Gregory dePrisco, Seth A Hays, Michael P Kilgard, Robert L Rennaker and 1 more

Abstract read
In one paragraph

Article in Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Joseph D EppersonTexas Biomedical Device Center, 800 W. Campbell Road, Richardson, TX 75080-3021, USA; Department of Bioengineering, Erik Jonsson School of Engineering and Computer Science, The University of Texas at Dallas, 860 N Loop Rd, Richardson, TX 75080, USA. Electronic address: joseph.epperson@utdallas.edu.
Michael L ForemanDivision of Acute Care Surgery, Baylor University Medical Center, 3500 Gaston Ave, Dallas, TX 75246, USA.
Richard C NaftalisDepartment of Neurosurgery, Baylor University of Medical Center, 3500 Gaston Ave, Dallas, TX 75246, USA.
Rita G HamiltonBaylor Scott and White Institute for Rehabilitation, 909 N Washington Ave, Dallas, TX 75246, USA.
Mark B PowersDivision of Acute Care Surgery, Baylor University Medical Center, 3500 Gaston Ave, Dallas, TX 75246, USA; Baylor Scott and White Research Institute, 3434 Live Oak St Ste 501, Dallas, TX 75204, USA.
Holle L GallawayTexas Biomedical Device Center, 800 W. Campbell Road, Richardson, TX 75080-3021, USA.
Gregory dePriscoDepartment of Radiology, Baylor University Medical Center, 3500 Gaston Ave, Dallas, TX 75246, USA.
Seth A HaysTexas Biomedical Device Center, 800 W. Campbell Road, Richardson, TX 75080-3021, USA; Department of Bioengineering, Erik Jonsson School of Engineering and Computer Science, The University of Texas at Dallas, 860 N Loop Rd, Richardson, TX 75080, USA.
Michael P KilgardTexas Biomedical Device Center, 800 W. Campbell Road, Richardson, TX 75080-3021, USA; Department of Bioengineering, Erik Jonsson School of Engineering and Computer Science, The University of Texas at Dallas, 860 N Loop Rd, Richardson, TX 75080, USA; Department of Neuroscience, School of Behavioral and Brain Sciences, The University of Texas at Dallas, GR41, 800 W Campbell Road, Richardson, TX 75080-3021, USA.
Robert L RennakerTexas Biomedical Device Center, 800 W. Campbell Road, Richardson, TX 75080-3021, USA; Department of Neuroscience, School of Behavioral and Brain Sciences, The University of Texas at Dallas, GR41, 800 W Campbell Road, Richardson, TX 75080-3021, USA; XNerve Medical Inc, 500 N. Central Expressway, Suite 500AC, Plano, TX 75074, USA.
Jane G WiggintonTexas Biomedical Device Center, 800 W. Campbell Road, Richardson, TX 75080-3021, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Vagus nerve stimulation (VNS) is widely used to treat various neurological and psychiatric conditions, including epilepsy and treatment-resistant depression, as well as to enhance motor rehabilitation following stroke. Conventional VNS devices have demonstrated reliability over decades of use, though recent advancements in technology offer new opportunities to further enhance the device. Many emerging indications require only intermittent stimulation, allowing for the development of a miniature externally powered implantable stimulator (MEPS) that is approximately 50 times smaller than conventional devices, is implanted with a single incision, has no battery or leads, and enables paired stimulation. Our observations compiled from three clinical trials with the MEPS device tested the hypotheses that removing the implanted battery and reducing device size would (1) shorten the surgical procedure and (2) maintain or improve safety outcomes. Data were collected from individuals with stroke, spinal cord injury, or post-traumatic stress disorder. Operative time was significantly reduced, averaging 38 ​± ​1 ​min compared to 76 ​± ​3 ​min for conventional VNS, with no significant intraoperative complications and no revision surgeries. The MEPS device successfully delivered 481,995 stimulations during 2205 ​h of therapy. One participant underwent an MRI outside the study, indicating compatibility with standard imaging protocols. Device-related adverse events occurred at a low rate; all were mild and resolved before study end. Overall, the MEPS device demonstrated a favorable safety and performance profile in a select population, with fewer occurrences of certain adverse events, extending the strong safety record of conventional VNS systems.

Indexed as

Electrodes, ImplantedImplantable NeurostimulatorsVagus Nerve StimulationAdultAgedFemaleHumansMaleMiddle AgedSpinal Cord InjuriesNeuromodulationPost-traumatic stress disorderSpinal cord injuryStrokeVagus nerve stimulation

Identifiers

PMID40579354
PMCPMC12491804

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.