NCT06460363

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".

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
33mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Sep 2024Dec 2028

First Submitted

Initial submission to the registry

June 3, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 6, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

3.3 years

First QC Date

June 3, 2024

Last Update Submit

October 2, 2024

Conditions

Delirium

Keywords

DeliriumTacsBrain stimulationIntensive care

Outcome Measures

Primary Outcomes (1)

  • Days alive and free of delirium or coma

    Days alive and free of delirium or coma

    28 days

Secondary Outcomes (6)

  • Biomarker profile

    4 days

  • EEG changes

    2 days

  • CERAD

    3 and 12 months

  • TMT test A

    3 and 12 months

  • TMT test B

    3 and 12 months

  • +1 more secondary outcomes

Study Arms (2)

Transcranial alternating current stimulation (TACS)

EXPERIMENTAL

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.

Device: Transcranial alternating current stimulation (TACS)

Sham TACS

SHAM COMPARATOR

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.

Device: Sham TACS

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.

Transcranial alternating current stimulation (TACS)
Sham TACSDEVICE

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

Sham TACS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Finland

RECRUITING

MeSH Terms

Conditions

DeliriumSpondylocostal Dysostosis 4, Autosomal Dominant

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Stepani Bendel

    Kuopio University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ville Ihalainen

CONTACT

+358 447176388ville.ihalainen@pshyvinvointialue.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 14, 2024

Study Start

September 6, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

October 4, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)