protocolSection identificationModule nctId: NCT06285721, orgStudyIdInfo id: DELTES, briefTitle: Delirium Treatment With Transcranial Electrical Stimulation, acronym: DELTES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: A.J.C. Slooter, class: OTHER, collaborators name: Radboud University Medical Center, collaborators name: HagaZiekenhuis, descriptionModule briefSummary: The goal of this clinical trial is to investigate the effectiveness of standardized and personalized transcranial alternating current stimulation (tACS) in patients with postoperative delirium. To investigate this, will perform a double-blind, randomized, sham-controlled, multicenter trial.To test the safety and feasibility of tACS in delirious patients, the first 30 patients will be randomized to receive either active or sham tACS treatment in a 1:1 ratio through a pilot study. For the main phase of the study, patients will be randomized, resulting in an overall 1:1:1 allocation to standardized tACS, personalized tACS or sham treatment.Electroencephalogram (EEG) will be measured directly before and directly after the first stimulation session to assess whether tACS can reduce relative delta power. tACS or sham treatment will be given once daily for a maximum of 14 days, or until resolution of delirium or discharge (whichever comes first). During the treatment phase, presence and severity of delirium will be assessed daily. After the treatment phase, an additional EEG will be measured. Cognitive status will be assessed three months postoperative., conditionsModule conditions: Delirium, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 159, type: ESTIMATED, armsInterventionsModule interventions name: transcranial alternating current stimulation (tACS), interventions name: Sham transcranial alternating current stimulation (tACS), outcomesModule primaryOutcomes measure: Relative delta power, secondaryOutcomes measure: Duration of delirium, secondaryOutcomes measure: Severity of delirium, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Cognitive status three months post delirium, secondaryOutcomes measure: Subjective sensations during treatment, secondaryOutcomes measure: Average peak frequency, secondaryOutcomes measure: Phase Lag Index, secondaryOutcomes measure: Corrected Amplitude Envelope Correlation (AECc), secondaryOutcomes measure: Relative power, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Radboudumc, city: Nijmegen, state: Gelderland, zip: 6525 GA, country: Netherlands, contacts name: Indira Tendolkar, MD, PhD, role: CONTACT, geoPoint lat: 51.8425, lon: 5.85278, locations facility: HagaZiekenhuis, city: Den Haag, state: Zuid-Holland, zip: 2545 AA, country: Netherlands, contacts name: Thomas H Ottens, MD, PhD, role: CONTACT, geoPoint lat: 52.07667, lon: 4.29861, hasResults: False