Transcranial Alternating Current Stimulation on Patients with Delirium and Critical Illness: a Randomized, Controlled, Double Blind, Proof-of-concept Pilot Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Finland
Kuopio University Hospital
RECRUITING
Kuopio
Contact Information
Primary
Ville Ihalainen
ville.ihalainen@pshyvinvointialue.fi
+358 447176388
Time Frame
Start Date: 2024-09-06
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 78
Treatments
Experimental: 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.
Sham_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Kuopio University Hospital