Evidence map›Paper›PMID 39754196›Full record

ArticleTrials2025

Modulating delirium through stimulation (MoDeSt): study protocol for a randomized, double-blind, sham-controlled trial assessing the effect of postoperative transcranial electrical stimulation on delirium incidence.

Sophie Leroy, Viktor Bublitz, Ulrike Grittner, Robert Fleischmann, Falk von Dincklage, Daria Antonenko

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Trial
  2. Article
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

6 authors.

Sophie Leroy *Delirium Prevention Unit, Universitätsmedizin Greifswald, Fleischmannstraße 6, Greifswald, 17489, Germany. sophie.leroy@med.uni-greifswald.de.ORCID http://orcid.org/0009-0007-5302-2763
Viktor Bublitz *Department of Anesthesia, Intensive Care, Emergency and Pain Medicine, Universitätsmedizin Greifswald, Fleischmannstraße 6, Greifswald, 17489, Germany.
Ulrike GrittnerInstitute of Biometry and Clinical Epidemiology, Charité University Medicine Berlin, Charitéplatz 1, Berlin, 10117, Germany.
Robert Fleischmann *Delirium Prevention Unit, Universitätsmedizin Greifswald, Fleischmannstraße 6, Greifswald, 17489, Germany.
Falk von Dincklage *Department of Anesthesia, Intensive Care, Emergency and Pain Medicine, Universitätsmedizin Greifswald, Fleischmannstraße 6, Greifswald, 17489, Germany.
Daria Antonenko *Department of Neurology, Universitätsmedizin Greifswald, Fleischmannstraße 6, Greifswald, 17489, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPostoperative delirium (POD) is the most common neurological adverse event among elderly patients undergoing surgery. POD is associated with an increased risk for postoperative complications, long-term cognitive decline, an increase in morbidity and mortality as well as extended hospital stays. Delirium prevention and treatment options are currently limited. This study will evaluate the effect of transcranial electrical stimulation (tES) on the incidence of POD.

methodsWe will perform a randomized, double-blind, sham-controlled trial using single-session postoperative application of tES in the recovery room in 225 patients (> 65 years) undergoing elective major surgery. Patients will be randomly allocated (ratio 1:1:1) to one of three study groups: (1) alpha-tACS over posterior parietal cortex [2 mA, 20 min], (2) anodal tDCS over left dorsolateral prefrontal cortex [2 mA, 20 min], (3) sham [2 mA, 30 s]. Delirium will be screened twice daily with the 3-min diagnostic interview Confusion Assessment Method (3D-CAM) in the 5 days following surgery. The primary outcome is the incidence of POD defined as at least one positive screening during the five first postoperative days compared between tACS and sham groups. Secondary outcomes include delirium severity, duration, phenotype, postoperative pain, postoperative nausea and vomiting, electroencephalographic (EEG) markers, and fluid biomarkers. DISCUSSION: If effective, tES is a novel, easily applicable, non-invasive method to prevent the occurrence of POD. The comprehensive neurophysiological and biofluid assessments for markers of (neuro-)inflammation and neurodegeneration will shed light on the pathomechanisms behind POD and further elucidate the (after-)effects of tES. The potential implications for the postoperative recovery comprise enhanced patient safety, neurocognitive outcome, perioperative manageability but also reduced healthcare costs.

trial registrationGerman Clinical Trial Registry DRKS00033703. Registered on February 23, 2024.

Indexed as

DeliriumPostoperative ComplicationsRandomized Controlled Trials as TopicTranscranial Direct Current StimulationAgedDouble-Blind MethodFemaleHumansIncidenceMaleTime FactorsTreatment OutcomeAlphaEEGNon-invasive brain stimulationPostoperative deliriumTACSTDCS

Identifiers

PMID39754196
PMCPMC11697754

What Socratic holds

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Registered trials

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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.