DeliriumDeliTACSNCT06460363
Transcranial Alternating Current Stimulation on Patients with Delirium and Critical Illness (DeliTACS)
A study testing Transcranial alternating current stimulation (TACS) in people with Delirium, run by Kuopio University Hospital at 1 site in Finland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Transcranial alternating current stimulation (TACS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteFinland
- Study dates
- 6 Sep 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio
Ville Ihalainen, MD, +358447176388, ville.ihalainen@pshyvinvointialue.fi
About this study
Official title: Transcranial Alternating Current Stimulation on Patients with Delirium and Critical Illness: a Randomized, Controlled, Double Blind, Proof-of-concept Pilot Study
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".
Read the 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 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.
- Conditions
- Delirium
- Being tested
- Transcranial alternating current stimulation (TACS), Sham TACS
- Keywords
- Delirium, Tacs, Brain stimulation, Intensive care
- Medical subject headings
- Delirium, Spondylocostal Dysostosis 4, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 TACSDevice
Sham treatment with few seconds of actual electrical current and same electrode configuration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham TACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days alive and free of delirium or coma
Days alive and free of delirium or coma
Measured: 28 days
Secondary outcomes (6)
Biomarker profile
Concentrations of neurofilament light (nfl), glial fibrillary acid (gfap) and plasma tau (ptau) on days 0, 2 and 4
Measured: 4 days
EEG changes
EEG Spectral power
Measured: 2 days
CERAD
CERAD test (Consortium to Establish a Registry for Alzheimer's Disease)
Measured: 3 and 12 months
TMT test A
Trail Making Test A
Measured: 3 and 12 months
TMT test B
Trail Making Test B
Measured: 3 and 12 months
Short latency inhibition
Measurement of brain cholinergic function by short latency inhibition with transcranial magnetic stimulation
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start6 Sep 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stepani Bendel, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460363
- Sponsor's protocol ID
- KUH507T056
- Acronym
- DeliTACS
- Status last verified
- Oct 2024
- First submitted
- 3 Jun 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Alternating Current Stimulation on Patients with Delirium and Critical Illness: a Randomized, Controlled, Double Blind, Proof-of-concept Pilot Study
- ClinicalTrials.gov ID
- NCT06460363
- Acronym / sponsor ID
- DeliTACS / KUH507T056
- Conditions
- Delirium
- Keywords
- Delirium, Tacs, Brain stimulation, Intensive care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial alternating current stimulation (TACS) | Experimental | Device: 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 TACS | Sham comparator | Device: Sham TACSThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Transcranial alternating current stimulation (TACS) |
| Sham TACSSham treatment with few seconds of actual electrical current and same electrode configuration | Device | Sham TACS |
Primary outcome
Days alive and free of delirium or coma
Time frame: 28 days
Days alive and free of delirium or coma
6 secondary outcomes
Biomarker profile
Time frame: 4 days
EEG changes
Time frame: 2 days
CERAD
Time frame: 3 and 12 months
TMT test A
Time frame: 3 and 12 months
TMT test B
Time frame: 3 and 12 months
Short latency inhibition
Time frame: 3 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stepani Bendel principal investigator
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial alternating current stimulation (TACS) in people with Delirium, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ville Ihalainen (+358 447176388, ville.ihalainen@pshyvinvointialue.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days alive and free of delirium or coma (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.