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Transcranial alternating current stimulation as treatment for delirium: A multicenter randomized double-blind sham-controlled pilot study on safety and feasibility.

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Τίτλος: Transcranial alternating current stimulation as treatment for delirium: A multicenter randomized double-blind sham-controlled pilot study on safety and feasibility.
Συγγραφείς: van der A J; Department of Intensive Care Medicine and University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Department of Psychiatry and University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands. Electronic address: j.vandera-2@umcutrecht.nl., Lodema DY; Department of Intensive Care Medicine and University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Department of Psychiatry, University Medical Center Groningen and Brain Center for Cognitive Neuroscience, University of Groningen, Groningen, the Netherlands., van Dellen E; Department of Psychiatry and University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Department of Neurology, UZ Brussel and Vrije Universiteit Brussel, Brussels, Belgium., Tendolkar I; Donders Institute for Brain, Cognition and Behavior, Department of Psychiatry, Radboud University, Nijmegen, the Netherlands., Emmelot-Vonk MH; Department of Geriatrics, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands., Schutter DJLG; Experimental Psychology, Helmholtz Institute, Utrecht University, Utrecht, the Netherlands., de Haan W; Alzheimer Center and Department of Neurology, Amsterdam Neuroscience, VU University Medical Center, Amsterdam UMC, Amsterdam, the Netherlands., van den Boogaard M; Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, the Netherlands., Ottens TH; Department of Intensive Care Medicine and University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Intensive Care Unit, HagaZiekenhuis, The Hague, the Netherlands., Slooter AJC; Department of Intensive Care Medicine and University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Department of Neurology, UZ Brussel and Vrije Universiteit Brussel, Brussels, Belgium; Department of Psychiatry, University Medical Center Groningen and Brain Center for Cognitive Neuroscience, University of Groningen, Groningen, the Netherlands.
Πηγή: Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics [Neurotherapeutics] 2026 Sep; Vol. 23 (5), pp. e01037. Date of Electronic Publication: 2026 Aug 04.
Τύπος έκδοσης: Journal Article; Randomized Controlled Trial; Multicenter Study
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: Elsevier Inc. on behalf of American Society for Experimental NeuroTherapeutics Country of Publication: United States NLM ID: 101290381 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1878-7479 (Electronic) Linking ISSN: 18787479 NLM ISO Abbreviation: Neurotherapeutics Subsets: MEDLINE
Imprint Name(s): Publication: 2024- : [New York] : Elsevier Inc. on behalf of American Society for Experimental NeuroTherapeutics
Original Publication: Orlando, FL : Elsevier, c2007-
Ιατρικοί όροι (MeSH): Delirium*/therapy , Transcranial Direct Current Stimulation*/methods , Transcranial Direct Current Stimulation*/adverse effects, Humans ; Double-Blind Method ; Pilot Projects ; Female ; Male ; Aged ; Middle Aged ; Feasibility Studies ; Treatment Outcome ; Aged, 80 and over ; Electroencephalography
Περίληψη: Delirium is an acute neuropsychiatric syndrome with currently no effective treatment. The acute encephalopathy underlying delirium is characterized by diffuse oscillatory slowing on electroencephalography (EEG). Based on its capacity to modulate oscillatory activity, 10 Hz transcranial alternating current stimulation (tACS) is a potential hypothesis-driven intervention for delirium. Before investigating potential neurophysiological or clinical effects, it is necessary to establish whether tACS is feasible and safe in delirious patients. This pilot study investigated the feasibility and safety of tACS in 30 hospitalized patients aged ≥50 years with delirium. Participants were randomized double-blind to receive either daily 10 Hz frontal-occipital tACS or sham stimulation for up to 14 days. The first-session completion rate was 94% (active) and 92% (sham). Participants had a median of 3 eligible treatment days (interquartile range [IQR]:2-4). The active group completed a median of 2 tACS sessions (IQR:2-3) and the sham group a median of 3 (IQR:2-4), corresponding to treatment adherence rates of 69% (95% confidence interval [CI]:57-79) and 73% (95% CI:59-83), respectively. The intervention was well-tolerated with no stimulation-related serious adverse events (AEs). AE frequency did not differ between active (35%) and sham (31%) groups. Side effects were mild, transient cutaneous sensations. In conclusion, short-course exposure to 10 Hz tACS can be safely initiated in hospitalized older adults with delirium, with a high first-session completion rate while delivery of repeated daily sessions remained challenging. These findings support further investigation of tACS in delirium, including studies specifically designed to evaluate neurophysiological and clinical effects. Trial Registration: NCT06285721, registered on 2024-02-19.
(Copyright © 2026 The Author(s). Published by Elsevier Inc. All rights reserved.)
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Contributed Indexing: Keywords: Acute encephalopathy; Delirium; Non-invasive brain stimulation; Randomized controlled trial; Transcranial alternating current stimulation
Molecular Sequence: ClinicalTrials.gov NCT06285721
Entry Date(s): Date Created: 20260804 Date Completed: 20260922 Latest Revision: 20260924
Update Code: 20260925
PubMed Central ID: PMC13469962
DOI: 10.1016/j.neurot.2026.e01037
PMID: 42551052
Βάση Δεδομένων: MEDLINE
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  Data: Transcranial alternating current stimulation as treatment for delirium: A multicenter randomized double-blind sham-controlled pilot study on safety and feasibility.
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  Data: <searchLink fieldCode="AU" term="%22van+der+A+J%22">van der A J</searchLink>; Department of Intensive Care Medicine and University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Department of Psychiatry and University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands. Electronic address: j.vandera-2@umcutrecht.nl.<br /><searchLink fieldCode="AU" term="%22Lodema+DY%22">Lodema DY</searchLink>; Department of Intensive Care Medicine and University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Department of Psychiatry, University Medical Center Groningen and Brain Center for Cognitive Neuroscience, University of Groningen, Groningen, the Netherlands.<br /><searchLink fieldCode="AU" term="%22van+Dellen+E%22">van Dellen E</searchLink>; Department of Psychiatry and University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Department of Neurology, UZ Brussel and Vrije Universiteit Brussel, Brussels, Belgium.<br /><searchLink fieldCode="AU" term="%22Tendolkar+I%22">Tendolkar I</searchLink>; Donders Institute for Brain, Cognition and Behavior, Department of Psychiatry, Radboud University, Nijmegen, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Emmelot-Vonk+MH%22">Emmelot-Vonk MH</searchLink>; Department of Geriatrics, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Schutter+DJLG%22">Schutter DJLG</searchLink>; Experimental Psychology, Helmholtz Institute, Utrecht University, Utrecht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22de+Haan+W%22">de Haan W</searchLink>; Alzheimer Center and Department of Neurology, Amsterdam Neuroscience, VU University Medical Center, Amsterdam UMC, Amsterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22van+den+Boogaard+M%22">van den Boogaard M</searchLink>; Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Ottens+TH%22">Ottens TH</searchLink>; Department of Intensive Care Medicine and University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Intensive Care Unit, HagaZiekenhuis, The Hague, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Slooter+AJC%22">Slooter AJC</searchLink>; Department of Intensive Care Medicine and University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Department of Neurology, UZ Brussel and Vrije Universiteit Brussel, Brussels, Belgium; Department of Psychiatry, University Medical Center Groningen and Brain Center for Cognitive Neuroscience, University of Groningen, Groningen, the Netherlands.
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  Data: <searchLink fieldCode="JN" term="%22101290381%22">Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics</searchLink> [Neurotherapeutics] 2026 Sep; Vol. 23 (5), pp. e01037. <i>Date of Electronic Publication: </i>2026 Aug 04.
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  Data: Delirium is an acute neuropsychiatric syndrome with currently no effective treatment. The acute encephalopathy underlying delirium is characterized by diffuse oscillatory slowing on electroencephalography (EEG). Based on its capacity to modulate oscillatory activity, 10 Hz transcranial alternating current stimulation (tACS) is a potential hypothesis-driven intervention for delirium. Before investigating potential neurophysiological or clinical effects, it is necessary to establish whether tACS is feasible and safe in delirious patients. This pilot study investigated the feasibility and safety of tACS in 30 hospitalized patients aged ≥50 years with delirium. Participants were randomized double-blind to receive either daily 10 Hz frontal-occipital tACS or sham stimulation for up to 14 days. The first-session completion rate was 94% (active) and 92% (sham). Participants had a median of 3 eligible treatment days (interquartile range [IQR]:2-4). The active group completed a median of 2 tACS sessions (IQR:2-3) and the sham group a median of 3 (IQR:2-4), corresponding to treatment adherence rates of 69% (95% confidence interval [CI]:57-79) and 73% (95% CI:59-83), respectively. The intervention was well-tolerated with no stimulation-related serious adverse events (AEs). AE frequency did not differ between active (35%) and sham (31%) groups. Side effects were mild, transient cutaneous sensations. In conclusion, short-course exposure to 10 Hz tACS can be safely initiated in hospitalized older adults with delirium, with a high first-session completion rate while delivery of repeated daily sessions remained challenging. These findings support further investigation of tACS in delirium, including studies specifically designed to evaluate neurophysiological and clinical effects. Trial Registration: NCT06285721, registered on 2024-02-19.<br /> (Copyright © 2026 The Author(s). Published by Elsevier Inc. All rights reserved.)
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  Data: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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  Data: <i>Keywords: </i>Acute encephalopathy; Delirium; Non-invasive brain stimulation; Randomized controlled trial; Transcranial alternating current stimulation
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