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

Sponsor
Kuopio University Hospital
Study ID
NCT06460363
Status
Recruiting
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Conditions

  • Delirium

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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".

Key Dates

First listed
Jun 14, 2024
Start date
Sep 6, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Days alive and free of delirium or coma [ Time Frame: 28 days ]

Central Contacts

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