Safety and tolerability of adjunct non-invasive vagus nerve stimulation in people with parkinson’s: a study protocol Article Swipe
Hilmar P. Sigurdsson
,
Heather L. Hunter
,
Lisa Alcock
,
Ross Wilson
,
Ilse S. Pienaar
,
Elizabeth J. Want
,
Mark R. Baker
,
John‐Paul Taylor
,
Lynn Rochester
,
Alison J. Yarnall
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1186/s12883-023-03081-1
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1186/s12883-023-03081-1
Background Parkinson’s disease (PD) is the fastest growing neurological condition worldwide. Recent theories suggest that symptoms of PD may arise due to spread of Lewy-body pathology where the process begins in the gut and propagate transynaptically via the vagus nerve to the central nervous system. In PD, gait impairments are common motor manifestations that are progressive and can appear early in the disease course. As therapies to mitigate gait impairments are limited, novel interventions targeting these and their consequences, i.e., reducing the risk of falls, are urgently needed. Non-invasive vagus nerve stimulation (nVNS) is a neuromodulation technique targeting the vagus nerve. We recently showed in a small pilot trial that a single dose of nVNS improved (decreased) discrete gait variability characteristics in those receiving active stimulation relative to those receiving sham stimulation. Further multi-dose, multi-session studies are needed to assess the safety and tolerability of the stimulation and if improvement in gait is sustained over time. Design This will be an investigator-initiated, single-site, proof-of-concept, double-blind sham-controlled randomised pilot trial in 40 people with PD. Participants will be randomly assigned on a 1:1 ratio to receive either active or sham transcutaneous cervical VNS. All participants will undergo comprehensive cognitive, autonomic and gait assessments during three sessions over 24 weeks, in addition to remote monitoring of ambulatory activity and falls, and exploratory analyses of cholinergic peripheral plasma markers. The primary outcome measure is the safety and tolerability of multi-dose nVNS in PD. Secondary outcomes include improvements in gait, cognition and autonomic function that will be summarised using descriptive statistics. Discussion This study will report on the proportion of eligible and enrolled patients, rates of eligibility and reasons for ineligibility. Adverse events will be recorded informing on the safety and device tolerability in PD. This study will additionally provide us with information for sample size calculations for future studies and evidence whether improvement in gait control is enhanced when nVNS is delivered repeatedly and sustained over time. Trial registration This trial is prospectively registered at www.isrctn.com/ISRCTN19394828 . Registered August 23, 2021.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1186/s12883-023-03081-1
- https://bmcneurol.biomedcentral.com/counter/pdf/10.1186/s12883-023-03081-1
- OA Status
- gold
- Cited By
- 8
- References
- 67
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4319162193
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W4319162193Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1186/s12883-023-03081-1Digital Object Identifier
- Title
-
Safety and tolerability of adjunct non-invasive vagus nerve stimulation in people with parkinson’s: a study protocolWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2023Year of publication
- Publication date
-
2023-02-03Full publication date if available
- Authors
-
Hilmar P. Sigurdsson, Heather L. Hunter, Lisa Alcock, Ross Wilson, Ilse S. Pienaar, Elizabeth J. Want, Mark R. Baker, John‐Paul Taylor, Lynn Rochester, Alison J. YarnallList of authors in order
- Landing page
-
https://doi.org/10.1186/s12883-023-03081-1Publisher landing page
- PDF URL
-
https://bmcneurol.biomedcentral.com/counter/pdf/10.1186/s12883-023-03081-1Direct link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
-
https://bmcneurol.biomedcentral.com/counter/pdf/10.1186/s12883-023-03081-1Direct OA link when available
- Concepts
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Tolerability, Vagus nerve stimulation, Medicine, Neurology, Neuromodulation, Neurostimulation, Physical medicine and rehabilitation, Vagus nerve, Adverse effect, Physical therapy, Anesthesia, Stimulation, Internal medicine, PsychiatryTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
8Total citation count in OpenAlex
- Citations by year (recent)
-
2025: 4, 2024: 2, 2023: 2Per-year citation counts (last 5 years)
- References (count)
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67Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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| primary_location.is_published | True |
| primary_location.raw_source_name | BMC Neurology |
| primary_location.landing_page_url | https://doi.org/10.1186/s12883-023-03081-1 |
| publication_date | 2023-02-03 |
| publication_year | 2023 |
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