Transcranial electrical stimulation for treating delirium

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of transcranial alternating current stimulation (tACS) in patients suffering from delirium. It employs a double-blind, randomized, sham-controlled design across multiple centers, with participants receiving either active or sham treatment. The study aims to assess the safety and feasibility of tACS, measuring its impact on EEG patterns associated with delirium. Patients will undergo daily treatment for up to 14 days, with outcomes evaluated based on changes in relative delta power and delirium severity.

Why it matters

Who can join: the full rules

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.

Where it's running

• Radboudumc
  Nijmegen, Gelderland, Netherlands Recruiting
• HagaZiekenhuis
  The Hague, South Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Arjen JC Slooter, MD, PhD — UMC Utrecht
• Study coordinator: Yorben Lodema, MD
• Email: deltes@umcutrecht.nl
• Phone: 088 7558300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.