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

NCT ID: NCT06460363

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-06
• Study Completion Date: 2028-12-31

Brief Summary

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".

Detailed Description

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.

Conditions

Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Transcranial alternating current stimulation (TACS)

Experimental intervention is alternating sinusoidal current at frequency of 40 Hz applied for 60 min through a pair of saline-soaked surface sponge electrodes. One electrode is placed with the center over Pz position according to the 10-20 international EEG coordinates (an area overlying the medial parietal cortex and the precuneus) and the other over the right deltoid muscle.

Group Type: EXPERIMENTAL

Transcranial alternating current stimulation (TACS)

Intervention Type: 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

The same electrodes are connected to the patient as in trial intervention. In sham treatment, a few seconds of actual current is provided and then the device automatically turns off. This is to ensure that patients cannot distinguish between real and sham treatments based on possible tingling of skin when starting the electrical current.

Group Type: SHAM_COMPARATOR

Sham TACS

Intervention Type: DEVICE

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

Interventions

Transcranial alternating current stimulation (TACS)

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

Intervention Type: DEVICE

Sham TACS

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kuopio University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stepani Bendel

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Locations

Kuopio University Hospital

Kuopio, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Ville Ihalainen

Role: CONTACT

ville.ihalainen@pshyvinvointialue.fi

+358 447176388

Facility Contacts

Ville Ihalainen, MD

Role: primary

ville.ihalainen@pshyvinvointialue.fi

+358447176388

Other Identifiers

KUH507T056

Identifier Type: -

Identifier Source: org_study_id