Safety and tolerability of adjunct non-invasive vagus nerve stimulation in people with parkinson's: a study protocol.
Attention
Cholinergic system
Gait
Parkinsons disease
Vagus nerve stimulation
Journal
BMC neurology
ISSN: 1471-2377
Titre abrégé: BMC Neurol
Pays: England
ID NLM: 100968555
Informations de publication
Date de publication:
03 Feb 2023
03 Feb 2023
Historique:
received:
18
12
2022
accepted:
19
01
2023
entrez:
4
2
2023
pubmed:
5
2
2023
medline:
8
2
2023
Statut:
epublish
Résumé
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. 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. 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. This trial is prospectively registered at www.isrctn.com/ISRCTN19394828 . Registered August 23, 2021.
Sections du résumé
BACKGROUND
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
METHODS
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
CONCLUSIONS
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
BACKGROUND
This trial is prospectively registered at www.isrctn.com/ISRCTN19394828 . Registered August 23, 2021.
Identifiants
pubmed: 36737716
doi: 10.1186/s12883-023-03081-1
pii: 10.1186/s12883-023-03081-1
pmc: PMC9896761
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
58Subventions
Organisme : Parkinson's UK
ID : G-1903
Pays : United Kingdom
Organisme : Parkinson's UK
ID : G-1903
Pays : United Kingdom
Organisme : Parkinson's UK
ID : G-1903
Pays : United Kingdom
Organisme : Parkinson's UK
ID : G-1903
Pays : United Kingdom
Organisme : Dunhill Medical Trust
ID : RPGF1906\154
Organisme : Dunhill Medical Trust
ID : RPGF1906\154
Organisme : Dunhill Medical Trust
ID : RPGF1906\154
Organisme : Dunhill Medical Trust
ID : RPGF1906\154
Informations de copyright
© 2023. The Author(s).
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