Evidence map›Paper›PMID 38134136›Full record

ArticlePloS one2023

Transauricular nerve stimulation in acute ischaemic stroke requiring mechanical thrombectomy: Protocol for a phase 2A, proof-of-concept, sham-controlled randomised trial.

Gareth L Ackland, Tim Martin, Mareena Joseph, Priyanthi Dias, Rizwan Hameed, Ana Gutierrez Del Arroyo, Russ Hewson, Tom E F Abbott, Oliver Spooner, Pervinder Bhogal

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05417009 (Vagal Autonomic Neuromodulation by Transcutaneous Nerve Stimulation in Acute Ischaemic Stroke Requiring Mechanical Thrombectomy.), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 38% of its field
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.

NCT05417009 nacompletednot on this map

Vagal Autonomic Neuromodulation by Transcutaneous Nerve Stimulation in Acute Ischaemic Stroke Requiring Mechanical Thrombectomy.

TypeinterventionalSponsorQueen Mary University of LondonRan2023 to 2023Enrolled36ConditionsIschemic Stroke, Thrombotic Stroke, Autonomic Dysfunction, Autonomic ImbalanceArmstrans-cutaneous auricular sensory stimulation
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  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

10 authors at 2 institutions in 1 country.

Gareth L AcklandTranslational Medicine and Therapeutics, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary, University of London, London, United Kingdom.ORCID 0000-0003-0565-5164
Tim MartinTranslational Medicine and Therapeutics, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary, University of London, London, United Kingdom.
Mareena JosephTranslational Medicine and Therapeutics, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary, University of London, London, United Kingdom.
Priyanthi DiasTranslational Medicine and Therapeutics, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary, University of London, London, United Kingdom.ORCID 0000-0003-1740-6165
Rizwan HameedTranslational Medicine and Therapeutics, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary, University of London, London, United Kingdom.ORCID 0000-0002-7083-3062
Ana Gutierrez Del ArroyoTranslational Medicine and Therapeutics, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary, University of London, London, United Kingdom.
Russ HewsonTranslational Medicine and Therapeutics, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary, University of London, London, United Kingdom.
Tom E F AbbottTranslational Medicine and Therapeutics, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary, University of London, London, United Kingdom.ORCID 0000-0002-8664-3001
Oliver SpoonerDepartment of Stroke Medicine, London, Royal London Hospital, London, Barts Health NHS Trust, London, United Kingdom.
Pervinder BhogalDepartment of Interventional Neuroradiology, Royal London Hospital, London, Barts Health NHS Trust, London, United Kingdom.
Queen Mary University of London · GBBarts Health NHS Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLabile blood pressure after acute ischaemic stroke requiring mechanical thrombectomy is independently associated with poor patient outcomes.

objectivesThis study protocol describes is designed to determine whether transauricular nerve stimulation, improves baroreflex sensitivity, reduces blood pressure variability in the first 24 hours after acute ischaemic stroke requiring mechanical thrombectomy.

designPHASE 2A, PROOF-OF-CONCEPT, SHAM-CONTROLLED RANDOMISED TRIAL: Methods and Analysis: 36 individuals undergoing mechanical thrombectomy for acute ischaemic stroke with established hypertension aged >18 years will be randomly allocated to receive bilateral active or sham transauricular nerve stimulation for the duration of the mechanical thrombectomy procedure (AffeX-CT/001 investigational device). The intervention will be repeated for 1h the morning following the mechanical thrombectomy. Non-invasive blood pressure will be measured ≥2h for 24h after mechanical thrombectomy. Holter electrocardiographic monitoring will be recorded during transauricular nerve stimulation. Participants, clinicians and investigators will be masked to treatment allocations. The primary outcome will be the coefficient of variation of systolic blood pressure. Secondary outcomes include additional estimates of blood pressure variability and time/frequency-domain measures of autonomic cardiac modulation An adjusted sample size of 36 patients is required to have a 90% chance of detecting, as significant at the 5% level, a difference in the coefficient of variation in systolic blood pressure of 5±4mmHg between sham and active stimulation [assuming 5% non-compliance rate in each group]. Ethics: confirmed on 16 March 2023 by HRA and Health and Care Research Wales ethics committee (reference 23/WA/0013). DISCUSSION: This study will provide proof-of-concept data that examines whether non-invasive autonomic neuromodulation can be used to favourably modify blood pressure and autonomic control after acute ischaemic stroke requiring mechanical thrombectomy.

trial registrationTrial registration number: NCT05417009.

Indexed as

Brain IschemiaIschemic StrokeStrokeClinical Trials, Phase II as TopicHumansRandomized Controlled Trials as TopicThrombectomyTreatment Outcome

Identifiers

PMID38134136
PMCPMC10745208
OpenAlexW4390100303

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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 Socratic graph.