Using brain stimulation to reduce delirium in ICU patients
Transcranial Alternating Current Stimulation on Patients with Delirium and Critical Illness: a Randomized, Controlled, Double Blind, Proof-of-concept Pilot Study
This study is testing if a type of brain stimulation can help ICU patients recover from delirium faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kuopio University Hospital Academic / other |
| Locations | 1 site (Kuopio) |
| Trial ID | NCT06460363 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if transcranial alternating current stimulation (TACS) can effectively shorten the duration of delirium in patients in an intensive care unit (ICU). Participants will receive either the experimental TACS treatment or a sham treatment over a maximum of two days, depending on their delirium status. The primary outcome measured will be the number of days patients are alive and free of delirium. The study is based on the premise that TACS can modulate brain activity and improve cognitive functions, potentially addressing the underlying pathophysiology of delirium.
Who should consider this trial
Good fit: Ideal candidates are ICU patients experiencing delirium for more than 24 hours.
Not a fit: Patients under 18 years of age, pregnant women, or those with a history of seizures or severe neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the duration of delirium in ICU patients, leading to better recovery outcomes.
How similar studies have performed: While TACS has shown promise in improving cognitive functions in other conditions, this specific application for delirium in ICU patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Delirium in intensive care and duration of delirium for more than 24 hours. Delirium is defined as 4 or more points on ICDSC and -1 or more points on RASS. Exclusion Criteria: * Under 18 years of age, pregnancy, delirium tremens, epilepsy or history of seizures any time before first trial intervention, active psychotic disease, infection of central nervous system, acute intoxication, traumatic brain injury, stroke, intracranial bleeding and implanted electronic devices.
Where this trial is running
Kuopio
- Kuopio University Hospital — Kuopio, Finland (Recruiting)
Study contacts
- Principal investigator: Stepani Bendel — Kuopio University Hospital
- Study coordinator: Ville Ihalainen
- Email: ville.ihalainen@pshyvinvointialue.fi
- Phone: +358 447176388
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.