Transcranial electrical stimulation for treating delirium
DELirium Treatment With Transcranial Electrical Stimulation
This study is testing if a new type of brain stimulation can help people with delirium feel better and improve their brain activity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 159 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 2 sites (Nijmegen, Gelderland and 1 other locations) |
| Trial ID | NCT06285721 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals over 50 years old diagnosed with delirium and exhibiting a Richmond Agitation and Sedation Scale score between -2 and +2.
Not a fit: Patients with dementia, severe cognitive impairment, or those unable to participate in delirium assessments will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the duration and severity of delirium in affected patients.
How similar studies have performed: While the use of tACS is a novel approach for treating delirium, similar studies have shown promise in improving cognitive functions in other conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nijmegen, Gelderland and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.