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NCT Number: NCT06460363

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

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".

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Delirium is an acute-onset brain dysfunction related to extensive surgery or critical illness that leads to altered mental status and cognitive deficits. Delirium is associated with an increased length of stay in the ICU, cost of care, excessive mortality, and long-term cognitive and functional impairment. Although numerous prophylactic methods have been proposed, currently, no pharmacological or non-pharmacological methods are clinically effective. Patients with delirium have altered electroencephalography (EEG) findings among which most important are general slowing of EEG frequencies and dysconnectivity. Faster EEG frequencies, especially alpha-, beta-, and gamma-bands, are correlated with higher cognitive functions, such as memory and orientation. Transcranial alternating current stimulation (TACS) is a novel, noninvasive brain stimulation technology that cab modulate EEG frequencies by entraining of endogenous brain oscillations in response to exogenous stimuli. TACS has been shown to improve episodic memory, orientation, and cholinergic dysfunction in patients with Alzheimer's disease. TACS also increases alpha and gamma frequencies in EEG, and an increase in these frequencies is associated with the improvement of clinical symptoms. TACS has been shown to target key components of delirium pathophysiology, such as slowing of EEG frequencies and cholinergic dysfunction. Thus, we hypothesized that TACS could shorten the duration of delirium and decrease cognitive decline. We aim to test this hypothesis in a double-blind randomized trial and assess the effect of TACS on duration of delirium, EEG, biomarkers and long-term cognition.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Days alive and free of delirium or coma

    Time frame: 28 days

    Days alive and free of delirium or coma

Secondary outcomes

  1. Biomarker profile

    Time frame: 4 days

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

  2. EEG changes

    Time frame: 2 days

    EEG Spectral power

  3. CERAD

    Time frame: 3 and 12 months

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

  4. TMT test A

    Time frame: 3 and 12 months

    Trail Making Test A

  5. TMT test B

    Time frame: 3 and 12 months

    Trail Making Test B

  6. Short latency inhibition

    Time frame: 3 and 12 months

    Measurement of brain cholinergic function by short latency inhibition with transcranial magnetic stimulation

Study contacts

Contact information is provided by the study sponsor or research team.

Ville Ihalainen

CONTACT

[email protected]

+358 447176388

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Official study title

Transcranial Alternating Current Stimulation on Patients with Delirium and Critical Illness: a Randomized, Controlled, Double Blind, Proof-of-concept Pilot Study

Acronym: DeliTACS

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jun 14, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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