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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06460363
Other study ID # KUH507T056
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2024
Est. completion date December 31, 2028

Study information

Verified date June 2024
Source Kuopio University Hospital
Contact Ville Ihalainen
Phone +358 447176388
Email ville.ihalainen@pshyvinvointialue.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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".


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 78
Est. completion date December 31, 2028
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.
Sham TACS
Sham treatment with few seconds of actual electrical current and same electrode configuration

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kuopio University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Days alive and free of delirium or coma Days alive and free of delirium or coma (ICDSC < 4 and RASS > -2) 28 days
Secondary Biomarker profile Concentrations of neurofilament light (nfl), glial fibrillary acid (gfap) and plasma tau (ptau) on days 0, 2 and 4 4 days
Secondary EEG changes EEG Spectral power 2 days
Secondary CERAD CERAD test (Consortium to Establish a Registry for Alzheimer's Disease) 3 and 12 months
Secondary TMT test A Trail Making Test A 3 and 12 months
Secondary TMT test B Trail Making Test B 3 and 12 months
Secondary Short latency inhibition Measurement of brain cholinergic function by short latency inhibition with transcranial magnetic stimulation 3 and 12 months
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