Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460363
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-03
Brief Title:
Transcranial Alternating Current Stimulation on Patients with Delirium and Critical Illness DeliTACS
Sponsor:
Kuopio University Hospital
Organization:
Kuopio University Hospital
Study Overview
Official Title:
Transcranial Alternating Current Stimulation on Patients with Delirium and Critical Illness a Randomized Controlled Double Blind Proof-of-concept Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DeliTACS
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
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 Alzheimers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None