NCT06285721 Delirium Treatment With Transcranial Electrical Stimulation
| NCT ID | NCT06285721 |
| Status | Recruiting |
| Phase | — |
| Sponsor | A.J.C. Slooter |
| Condition | Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 159 participants |
| Start Date | 2024-04-24 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 159 participants in total. It began in 2024-04-24 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to investigate the effectiveness of standardized and personalized transcranial alternating current stimulation (tACS) in patients with 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 after the initial tACS session.
Eligibility Criteria
Inclusion Criteria: * Age over 50 years. * Diagnosis of delirium * Richmond Agitation and Sedation Scale (RASS) score of -2 to +2. * Delirium duration of at least two days prior to study inclusion, based delirium assessments and/or descriptions in the medical and/or nursing files. * Known causes underlying delirium are being treated adequately, as assessed by the treating physician. Exclusion Criteria: * Inability to conduct delirium assessment (e.g. coma, deaf, blind) or inability to speak Dutch or English. * A moribund state. * Alcohol/substance abuse withdrawal or stroke as precipitating factor for delirium. * Diagnosis of dementia, based on medical record review and/or a score of ≥4.5 on the short form of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) * One or more contra-indications for tACS: 1. History of serious head trauma or brain surgery; 2. Large or ferromagnetic metal parts in the head (except for a dental wire); 3. Implanted cardiac pacemaker or neurostimulator; 4. Skin diseases or inflammations; 5. Epilepsy.
Contact & Investigator
Arjen JC Slooter, MD, PhD
PRINCIPAL INVESTIGATOR
UMC Utrecht
Frequently Asked Questions
Who can join the NCT06285721 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06285721 currently recruiting?
Yes, NCT06285721 is actively recruiting participants. Contact the research team at deltes@umcutrecht.nl for enrollment information.
Where is the NCT06285721 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands, The Hague, Netherlands.
Who is sponsoring the NCT06285721 clinical trial?
NCT06285721 is sponsored by A.J.C. Slooter. The principal investigator is Arjen JC Slooter, MD, PhD at UMC Utrecht. The trial plans to enroll 159 participants.