Safety and feasibility of transcutaneous vagus nerve stimulation in mild cognitive impairment: VINCI-AD study protocol.
Autonomic Nervous System
Cognitive dysfunction
Mild Cognitive Impairment
Nerve stimulation, transcutaneous
Vagus nerve stimulation
Journal
BMC neurology
ISSN: 1471-2377
Titre abrégé: BMC Neurol
Pays: England
ID NLM: 100968555
Informations de publication
Date de publication:
02 Aug 2023
02 Aug 2023
Historique:
received:
19
04
2023
accepted:
05
07
2023
medline:
4
8
2023
pubmed:
3
8
2023
entrez:
2
8
2023
Statut:
epublish
Résumé
Over 55 million adults are living with dementia globally, which is projected to reach 157 million by 2050. Mild cognitive impairment (MCI), a syndrome of memory impairment with intact activities of daily living, may precede dementia by several years. Around 5-15% of individuals with MCI convert to dementia annually. Novel treatments which delay progression of MCI to dementia are urgently needed. Transcutaneous vagal nerve stimulation (tVNS) is a non-invasive neuromodulation technique that targets the vagus nerve. Importantly, tVNS has been shown to improve cognition in healthy volunteers, but has not been extensively examined as a potential therapeutic approach in MCI. VINCI-AD will examine the safety and feasibility of tVNS in older adults with MCI. VINCI-AD is an investigator-led, single-site, single-blind, sham-controlled crossover pilot study which aims to assess the safety and feasibility of tVNS in 40 participants with amnestic MCI. All participants will attend for three consecutive study visits during which they will be randomised to receive no stimulation (baseline), active tVNS stimulation (stimulation at cymba conchae of left ear) or sham tVNS stimulation (at earlobe). Safety will be primarily assessed by ascertainment of adverse events. Further safety assessment will examine the impact of acute tVNS on subjective (orthostatic symptoms), peripheral (finometry-based blood pressure) and central (assessed via Near Infrared Spectroscopy [NIRS]) haemodynamic responses to active stand. Feasibility will be determined using a custom-designed occupational assessment of device usability. Exploratory secondary analysis in VINCI-AD will examine the potential impact of acute tVNS on associative memory, spatial memory and inhibitory control to inform sample size estimates for future trials of tVNS in older adults with MCI. VINCI-AD will report on the safety (adverse events/haemodynamic responses to active stand) and feasibility of tVNS as a potential therapeutic option in MCI. Detailed reporting of study eligibility and completion rates will be reported. Exploratory analysis will examine the potential cognitive benefits of acute tVNS on cognitive function in MCI to report potential effect sizes that may inform future clinical trials in this cohort. https://clinicaltrials.gov/ct2/show/NCT05514756 . Trial Registration Number NCT05514756 (24th August 2022 for this protocol, version 1.0.).
Sections du résumé
BACKGROUND
BACKGROUND
Over 55 million adults are living with dementia globally, which is projected to reach 157 million by 2050. Mild cognitive impairment (MCI), a syndrome of memory impairment with intact activities of daily living, may precede dementia by several years. Around 5-15% of individuals with MCI convert to dementia annually. Novel treatments which delay progression of MCI to dementia are urgently needed. Transcutaneous vagal nerve stimulation (tVNS) is a non-invasive neuromodulation technique that targets the vagus nerve. Importantly, tVNS has been shown to improve cognition in healthy volunteers, but has not been extensively examined as a potential therapeutic approach in MCI. VINCI-AD will examine the safety and feasibility of tVNS in older adults with MCI.
DESIGN
METHODS
VINCI-AD is an investigator-led, single-site, single-blind, sham-controlled crossover pilot study which aims to assess the safety and feasibility of tVNS in 40 participants with amnestic MCI. All participants will attend for three consecutive study visits during which they will be randomised to receive no stimulation (baseline), active tVNS stimulation (stimulation at cymba conchae of left ear) or sham tVNS stimulation (at earlobe). Safety will be primarily assessed by ascertainment of adverse events. Further safety assessment will examine the impact of acute tVNS on subjective (orthostatic symptoms), peripheral (finometry-based blood pressure) and central (assessed via Near Infrared Spectroscopy [NIRS]) haemodynamic responses to active stand. Feasibility will be determined using a custom-designed occupational assessment of device usability. Exploratory secondary analysis in VINCI-AD will examine the potential impact of acute tVNS on associative memory, spatial memory and inhibitory control to inform sample size estimates for future trials of tVNS in older adults with MCI.
DISCUSSION
CONCLUSIONS
VINCI-AD will report on the safety (adverse events/haemodynamic responses to active stand) and feasibility of tVNS as a potential therapeutic option in MCI. Detailed reporting of study eligibility and completion rates will be reported. Exploratory analysis will examine the potential cognitive benefits of acute tVNS on cognitive function in MCI to report potential effect sizes that may inform future clinical trials in this cohort.
TRIAL REGISTRATION
BACKGROUND
https://clinicaltrials.gov/ct2/show/NCT05514756 . Trial Registration Number NCT05514756 (24th August 2022 for this protocol, version 1.0.).
Identifiants
pubmed: 37532979
doi: 10.1186/s12883-023-03320-5
pii: 10.1186/s12883-023-03320-5
pmc: PMC10394887
doi:
Banques de données
ClinicalTrials.gov
['NCT05514756']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
289Subventions
Organisme : Meath Foundation
ID : R118/2020
Informations de copyright
© 2023. The Author(s).
Références
J Auton Nerv Syst. 1996 Feb 5;57(1-2):123-7
pubmed: 8867095
J Intern Med. 2004 Sep;256(3):183-94
pubmed: 15324362
Neurophotonics. 2016 Jan;3(1):010801
pubmed: 26788547
J Clin Psychiatry. 2006 Aug;67(8):1171-8
pubmed: 16965193
Front Psychol. 2020 Jul 09;11:1276
pubmed: 32733306
Front Psychol. 2018 Jul 06;9:1159
pubmed: 30034357
J Clin Psychiatry. 2002 Nov;63(11):972-80
pubmed: 12444809
JAMA. 2022 Dec 20;328(23):2345-2356
pubmed: 36512367
J Alzheimers Dis. 2017;59(1):369-385
pubmed: 28671118
Med Acupunct. 2018 Jun 1;30(3):141-150
pubmed: 29937968
Neuropsychologia. 2018 Mar;111:72-76
pubmed: 29326067
Front Neurosci. 2021 Dec 23;15:790793
pubmed: 35002607
Ageing Res Rev. 2022 Jan;73:101539
pubmed: 34883203
Semin Neurol. 2007 Feb;27(1):22-31
pubmed: 17226738
Can J Neurol Sci. 2008 Jul;35(3):287-96
pubmed: 18714795
J Clin Exp Neuropsychol. 2017 Dec;39(10):954-964
pubmed: 28492363
Am J Public Health. 2010 Apr 1;100 Suppl 1:S105-12
pubmed: 20147682
Brain Stimul. 2016 Nov - Dec;9(6):811-818
pubmed: 27522167
BMC Neurosci. 2019 Jan 03;20(1):2
pubmed: 30602377
Neurology. 1998 Dec;51(6):1760-2
pubmed: 9855544
Front Aging Neurosci. 2020 Nov 30;12:605878
pubmed: 33424582
Neuropsychology. 2021 May;35(4):352-365
pubmed: 34043386
Nat Neurosci. 1999 Jan;2(1):94-8
pubmed: 10195186
Neurol Sci. 2022 Feb;43(2):999-1006
pubmed: 34255194
PLoS One. 2020 Sep 22;15(9):e0239077
pubmed: 32960930
J Am Geriatr Soc. 2022 Jul;70(7):1973-1986
pubmed: 35535653
Neurobiol Aging. 2015 May;36(5):1860-7
pubmed: 25805212
Neuropsychologia. 2011 Jul;49(9):2776-83
pubmed: 21689670
Brain Stimul. 2013 Sep;6(5):798-804
pubmed: 23453934
Neuropsychol Rev. 2021 Mar;31(1):139-166
pubmed: 32959167
Clin Auton Res. 2011 Apr;21(2):69-72
pubmed: 21431947
Neuroimage. 2012 Nov 1;63(2):921-35
pubmed: 22510258
J Neural Eng. 2009 Feb;6(1):016003
pubmed: 19104138
Eur Neuropsychopharmacol. 2015 Jun;25(6):773-8
pubmed: 25869158
Lancet Neurol. 2002 Dec;1(8):477-82
pubmed: 12849332
Neuromodulation. 2017 Apr;20(3):290-300
pubmed: 27898202
Brain Stimul. 2017 Jan - Feb;10(1):19-27
pubmed: 28104084
Cogn Behav Neurol. 2006 Sep;19(3):119-22
pubmed: 16957488
Epilepsy Behav. 2016 Nov;64(Pt A):171-179
pubmed: 27743550
J Clin Exp Neuropsychol. 2012;34(6):580-7
pubmed: 22765048
Am J Occup Ther. 2009 Sep-Oct;63(5):592-9
pubmed: 19785258
J Am Geriatr Soc. 2015 Sep;63(9):1868-73
pubmed: 26313614
Brain Res. 1995 May 15;679(2):227-40
pubmed: 7543355
J Cogn Neurosci. 2015 Nov;27(11):2126-32
pubmed: 26226074
Top Cogn Sci. 2023 Jan;15(1):120-138
pubmed: 34878689
Int J Alzheimers Dis. 2017;2017:5479597
pubmed: 28573062
Brain Stimul. 2018 Nov - Dec;11(6):1225-1238
pubmed: 30217648
J Psychiatr Res. 2020 May;124:58-76
pubmed: 32120065
Brain Stimul. 2022 Nov-Dec;15(6):1405-1414
pubmed: 36150665
Psychiatry (Edgmont). 2006 May;3(5):54-63
pubmed: 21103178
Auton Neurosci. 2022 Sep;241:103008
pubmed: 35724559
J Gerontol A Biol Sci Med Sci. 2020 Oct 15;75(11):2169-2176
pubmed: 32449919
Int J Psychophysiol. 2018 Jun;128:93-99
pubmed: 29574234
Eur J Neurosci. 2018 Sep;48(6):2301-2309
pubmed: 30144194