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De klinische studie NCT07258082 voor Delirium Treatment, Delirium is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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TaVNS for Delirium 10 Niet-invasief Korte termijn

Rekruterend
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De klinische studie NCT07258082 is een interventioneel studie bij Delirium Treatment, Delirium met de status rekruterend. Het doel is om 10 deelnemers te includeren vanaf 26 september 2025. De studie wordt geleid door Stony Brook-universiteit en de voltooiing is gepland op 1 oktober 2028. Laatste update op ClinicalTrials.gov: 2 december 2025.
Beknopte samenvatting
The goal of this clinical trial is to test whether a non-invasive device called transauricular vagus nerve stimulation (taVNS) is safe, practical, and potentially helpful for patients in the hospital who develop delirium. Delirium is a state of confusion that often happens to people in the hospital who are sick or hurt. It can cause agitation, trouble paying attention and difficulty understanding what is happening. D...Toon meer
Uitgebreide beschrijving
This will be a single-arm, open-label trial to assess the brain blood oxygen saturation and EEG of hospitalized patients with delirium, and to assess feasibility and safety of transauricular vagus nerve stimulation (taVNS) in this population. This is an early feasibility study and there is no randomization or placebo group. All patients enrolled will receive taVNS in addition to usual hospital care for delirium. We a...Toon meer
Officiële titel

Transauricular Vagus Nerve Stimulation (taVNS) for Delirium

Aandoeningen
Delirium TreatmentDelirium
Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:
Andere studie-ID's
  • IRB2025-00131
NCT-ID
NCT07258082
Startdatum (Werkelijk)
2025-09-26
Laatste update geplaatst
2025-12-02
Verwachte einddatum
2028-10
Inschrijving (Geschat)
10
Studietype
Interventioneel
FASE
N.v.t.
Status
Rekruterend
Trefwoorden
delirium
tavns
transauricular vagus nerve stimulation
vagus nerve stimulation
transcutaneous vagus nerve stimulation
Primaire doel
Haalbaarheid van medische hulpmiddelen
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelTaVNS and Usual Care for Delirium
Hospitalized, right-hand-dominant adults (age ≥ 22) with delirium, receive transauricular vagus nerve stimulation (taVNS) in addition to standard clinical management. TaVNS is administered twice a day, for a maximum of 7 days, until delirium resolves or the patient is discharged from the ICU.
Transauricular Vagus Nerve Stimulation
TaVNS starts within 24 hours of consent and is given twice daily (\~30 minutes per session, ≥6 hours apart) for up to 7 days or until delirium resolves. Stimulation will be delivered to the tragus of the left ear via non-invasive clip-on electrode. Stimulation parameters will be set to: pulse width 500 µs, frequency 25 Hz, 30 s on / 30 s off. Current amplitude will be titrated to perceptual threshold (0.5-5.0 mA); i...Toon meer
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Feasibility of taVNS in hospitalized patients with delirium
We will assess feasibility of taVNS as follows: The proportion of stimulation delivered relative to the stimulation prescribed, calculated as: Stimulation delivered (minutes) /Stimulation prescribed (minutes) Feasibility will be demonstrated if: 1. The mean proportion of stimulation delivered across the cohort is ≥10%. Previous taVNS studies in adults have demonstrated that as little as 6 minutes of stimulation is adequate to demonstrate neuromodulatory effect as detected by fMRI. In our protocol, patients will be prescribed a total of 60 minutes of stimulation per day of study 6 minutes of stimulation (a known minimum effective dose) is thus 10% of prescribed stimulation time. 2. At least 80% of patients achieve ≥10% of prescribed stimulation.
From enrollment to end of treatment at a maximum of 7 days
Feasibility of taVNS in delirious hospitalized patients
We will assess feasibility of taVNS as follows: The proportion of stimulation delivered relative to the stimulation prescribed, calculated as: Stimulation delivered (minutes) / Stimulation prescribed (minutes) Feasibility will be demonstrated if: 1. The mean proportion of stimulation delivered across the cohort is ≥10%. Previous taVNS studies in adults have demonstrated that as little as 6 minutes of stimulation is adequate to demonstrate neuromodulatory effect as detected by fMRI. In our protocol, patients will be prescribed a total of 60 minutes of stimulation per day of study. 6 minutes of stimulation (a known minimum effective dose) is thus 10% of prescribed stimulation time. 2. At least 80% of patients achieve ≥10% of prescribed stimulation.
From enrollment to the end of study at a maximum of 7 days
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
22 Years
Geslachten die in aanmerking komen voor de studie
Allen
  • Stony Brook University Hospital inpatient, Age > 22
  • Right- handed
  • Screen positive for delirium on CAM-ICU instrument

  • Severe neurologic disability including severe traumatic brain injury, severe permanent cognitive impairment
  • Pacemaker present
  • Implanted VNS stimulator present
  • Personal history of epilepsy
  • Facial or ear pain or trauma
  • Recent history of substance abuse
  • Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe.
  • Weight < 40kg
  • Pregnant females
  • Intubated patient
Stony Brook University logoStony Brook-universiteit
Verantwoordelijke instantie
Isadora Botwinick, Hoofdonderzoeker, Clinical Assistant Professor of Surgery, Stony Brook University
Centraal Contactpersoon
Contact: Isadora Botwinick, MD, 631-444-8329, [email protected]
Contact: Charles Mikell, MD, 631-444-9137, [email protected]
1 Studielocaties in 1 landen

New York

Stony Brook University Hospital, Stony Brook, New York, 11794, United States
Isadora Botwinick, MD, Contact, 631-444-8329, [email protected]
Charles Mikell, MD, Contact, 631-444-9137, [email protected]
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