Evidence map›Paper›PMID 38676623›Full record

ArticleEuropean stroke journal2024

Perispinal Etanercept to improve STroke Outcomes (PESTO): Protocol for a multicenter, international, randomized placebo-controlled trial.

Vincent Thijs, Geoffrey C Cloud, Nigel Gilchrist, Brooke Parsons, Forum Tilvawala, Jan Ho, Lara Ruthnam, Vimal Stanislaus, Nikola Sprigg, Marion Walker and 3 more

Open access · greenAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in European stroke journal, 2024. 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
0.8field-weighted citation impact, top 28% 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.

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, 2 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

13 authors at 5 institutions in 3 countries.

Vincent ThijsFlorey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, VIC, Australia.
Geoffrey C CloudDepartment of Neuroscience, Central Clinical School, Monash University Melbourne, Melbourne, VIC, Australia.
Nigel GilchristCGM Research Trust, Christchurch, New Zealand.
Brooke ParsonsFlorey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, VIC, Australia.
Forum TilvawalaDepartment of Neurology, Austin Health, Heidelberg, VIC, Australia.ORCID 0009-0007-1209-3880
Jan HoDepartment of Neurology, Austin Health, Heidelberg, VIC, Australia.
Lara RuthnamDepartment of Neurology, Austin Health, Heidelberg, VIC, Australia.
Vimal StanislausDepartment of Neuroscience, Central Clinical School, Monash University Melbourne, Melbourne, VIC, Australia.
Nikola SpriggStroke Trials Unit, Mental Health & Clinical Neuroscience, University of Nottingham, Nottingham, UK.
Marion WalkerStroke Trials Unit, Mental Health & Clinical Neuroscience, University of Nottingham, Nottingham, UK.
Philip M BathStroke Trials Unit, Mental Health & Clinical Neuroscience, University of Nottingham, Nottingham, UK.
Leonid ChurilovDepartment of Medicine, Melbourne Medical School, University of Melbourne, Heidelberg/Parkville, VIC Australia.
Julie BernhardtFlorey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, VIC, Australia.
The University of Melbourne · AUAustin Health · AUNottingham University Hospitals NHS Trust · GBAlfred Health · AUChristchurch Clinical Studies Trust · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleA large proportion of stroke survivors will have long-lasting, debilitating neurological impairments, yet few efficacious medical treatment options are available. Etanercept inhibits binding of tumor necrosis factor to its receptor and is used in the treatment of inflammatory conditions. Perispinal subcutaneous injection followed by a supine, head down position may bypass the blood brain barrier. In observational studies and one small randomized controlled trial the majority of patients showed improvement in multiple post stroke impairments.

aimPerispinal Etanercept to improve STroke Outcomes (PESTO) investigates whether perispinal subcutaneous injection of etanercept improves quality of life and is safe in patients with chronic, disabling, effects of stroke. METHODS AND

designPESTO is a multicenter, international, randomized placebo-controlled trial. Adult participants with a history of stroke between 1 and 15 years before enrollment and a current modified Rankin scale between 2 and 5 who are otherwise eligible for etanercept are randomized 1:1 to single dose injection of etanercept or placebo. STUDY OUTCOMES: The primary efficacy outcome is quality of life as measured using the Short Form 36 Health Inventory at day 28 after first injection. Safety outcomes include serious adverse events. SAMPLE SIZE TARGET: A total of 168 participants assuming an improvement of the SF-36 in 11% of participants in the control arm and in 30% of participants in the intervention arm, 80% power and 5% alpha. DISCUSSION: PESTO aims to provide level 1 evidence on the safety and efficacy of perispinal etanercept in patients with long-term disabling effects of stroke.

Indexed as

EtanerceptQuality of LifeStrokeAdultDouble-Blind MethodFemaleHumansInjections, SubcutaneousMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeEtanerceptchronic effects of strokeetanerceptimproving chronic effects of strokeperispinalplaceborandomized controlled trialRCTStrokestroke outcomesTNF-alpha

Identifiers

PMID38676623
PMCPMC11418453
OpenAlexW4395690417

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.