Transcranial Alternating Current Stimulation on Patients with Delirium and Critical Illness (DeliTACS)

ConditionDelirium
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKuopio University Hospital

About this trial

The goal of this clinical trial is to learn if transcranial alternating current stimulation can shorten the duration of delirium in intensive care setting. The main question it aims to answer:

* Is it possible to shorten the duration of delirium with transcranial alternating current stimulation?

Researchers will compare experimental treatment to sham.

Participants will receive experimental or sham treatment on maximum of two days depending on their delirium status. Duration of delirium is recorded and reported as "days alive and free of delirium".

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial alternating current stimulation (TACS)

    Device

    Transcranial alternating sinusoidal current at frequency of 40 Hz applied for 60 min through a pair of saline-soaked surface sponge electrodes.

  • Sham TACS

    Device

    Sham treatment with few seconds of actual electrical current and same electrode configuration

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Transcranial alternating current stimulation (TACS)Experimental treatment 1 intervention
Group B: Sham TACSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Days alive and free of delirium or coma

Days alive and free of delirium or coma

Time frame
28 days

Secondary outcomes

1

Biomarker profile

Concentrations of neurofilament light (nfl), glial fibrillary acid (gfap) and plasma tau (ptau) on days 0, 2 and 4

Time frame
4 days
2

EEG changes

EEG Spectral power

Time frame
2 days
3

CERAD

CERAD test (Consortium to Establish a Registry for Alzheimer's Disease)

Time frame
3 and 12 months
4

TMT test A

Trail Making Test A

Time frame
3 and 12 months

Other outcomes

Sponsors and contacts

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