DeliriumDELTESNCT06285721
Delirium Treatment With Transcranial Electrical Stimulation
A study testing transcranial alternating current stimulation (tACS) in people with Delirium, run by A.J.C. Slooter at 2 sites in Netherlands.
Trial summary
The goal of this clinical trial is to investigate the effectiveness of standardized and personalized transcranial alternating current stimulation (tACS) in patients with delirium. To investigate this, will perform a double-blind, randomized, sham-controlled, multicenter trial. Read more about this study
- Who is it for?
- Ages 50 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
- 159 participants
- Where
- 2 sitesNetherlands
- Study dates
- 24 Apr 2024to 31 Mar 2027
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 50 years.
- Diagnosis of delirium
- Richmond Agitation and Sedation Scale (RASS) score of -2 to +2.
- Delirium duration of at least two days prior to study inclusion, based delirium assessments and/or descriptions in the medical and/or nursing files.
- Known causes underlying delirium are being treated adequately, as assessed by the treating physician.
Who cannot join
- Inability to conduct delirium assessment (e.g. coma, deaf, blind) or inability to speak Dutch or English.
- A moribund state.
- Alcohol/substance abuse withdrawal or stroke as precipitating factor for delirium.
- Diagnosis of dementia, based on medical record review and/or a score of ≥4.5 on the short form of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
- One or more contra-indications for tACS:
- History of serious head trauma or brain surgery;
Show all 10Show fewer
- Large or ferromagnetic metal parts in the head (except for a dental wire);
- Implanted cardiac pacemaker or neurostimulator;
- Skin diseases or inflammations;
- Epilepsy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525 GA
Indira Tendolkar, MD, PhD
- Recruiting
HagaZiekenhuis
The Hague, South Holland, 2545 AA
Thomas H Ottens, MD, PhD
About this study
Official title: DELirium Treatment With Transcranial Electrical Stimulation
The goal of this clinical trial is to investigate the effectiveness of standardized and personalized transcranial alternating current stimulation (tACS) in patients with delirium. To investigate this, will perform a double-blind, randomized, sham-controlled, multicenter trial.
To test the safety and feasibility of tACS in delirious patients, the first 30 patients will be randomized to receive either active or sham tACS treatment in a 1:1 ratio through a pilot study. For the main phase of the study, patients will be randomized, resulting in an overall 1:1:1 allocation to standardized tACS, personalized tACS or sham treatment.
Electroencephalogram (EEG) will be measured directly before and directly after the first stimulation session to assess whether tACS can reduce relative delta power. tACS or sham treatment will be given once daily for a maximum of 14 days, or until resolution of delirium or discharge (whichever comes first). During the treatment phase, presence and severity of delirium will be assessed daily. After the treatment phase, an additional EEG will be measured. Cognitive status will be assessed three months after the initial tACS session.
Read the detailed description
Delirium, a prevalent neuropsychiatric syndrome caused by an underlying medical condition, characterized by cognitive deficits such as inattention, extends hospital stay, increases healthcare costs and increases the risk of long-term cognitive decline. Prolonged and severe delirium is associated with worse long-term outcomes. There is currently no treatment that reduces the duration or severity of delirium.
Delirium is consistently characterized by diffuse oscillatory slowing of the EEG, including pronounced loss of alpha activity and increased relative delta power. Additionally, functional connectivity between brain regions is decreased during delirium. In light of this, tACS is a potential treatment option that directly addresses the brain dysfunction observed in delirium. Because tACS has shown the ability to improve multiple domains of cognition, including attention, and modify functional connectivity, we aim to investigate the effectiveness of tACS as treatment for delirium. We will utilize the EEG to measure the effects of tACS, using relative delta power as a primary outcome measure.
Additionally, EEG measurements can capture individual spectral and connectivity changes targeted with tACS, making EEG a promising input for personalized tACS treatment. Neural mass modelling is a way to model the behavior of groups of neurons resulting in oscillatory output similar to EEG. This type of model is able to represent delirium pathology and, when combined with individual EEG input, can be employed to optimize treatment effectiveness, leading to personalized tACS treatment.
The overarching aim of the study is to investigate whether treatment with tACS, either standardized or personalized, induces EEG alterations indicative of reversal of delirium. The primary outcome is relative delta power in the EEG measured after the first tACS session. Secondary outcomes include severity and/or duration of delirium measured with validated delirium assessment instruments.
Patients aged 50 years and older with delirium that persists for at least 2 days, despite adequate treatment of underlying causes will be included in the study (n = 159). Inclusion will take place in the intensive care unit (ICU) and non-ICU wards of the University Medical Centre (UMC) Utrecht, Radboud UMC and HagaZiekenhuis.The proposed tACS protocol is considered safe according to the latest published international safety guidelines. All participants will be screened for their relevant medical history and other tACS safety aspects.
- Conditions
- Delirium
- Being tested
- transcranial alternating current stimulation (tACS), Sham transcranial alternating current stimulation (tACS)
- Keywords
- electroencephalography, transcranial alternating current stimulation
- Medical subject headings
- Delirium
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
tACS is a non-invasive brain stimulation technique which involves the application of a low intensity electric current between two or more surface electrodes. tACS uses stimulation with a current alternating at a specific frequency that can entrain endogenous neuronal oscillations by inducing neural synchronization. The administration of tACS is proposed to phase-lock large populations of neurons in the superficial layers of the cerebral cortex causing neural synchronization in the corresponding frequency, thereby altering connectivity. tACS will be delivered via a transcranial electrical stimulation (tES) device (Nurostym tES, Brainbox Ltd, United Kingdom). This device has been CE-marked for use as a medical device for the treatment of mental and neurological disorders.
Sham transcranial alternating current stimulation (tACS)Device
Sham-tACS is a form of non-effective stimulation which can mimic the subjective sensation of active tACS treatment. During sham-tACS, the device will ramp up to 2.0 mA peak-to-peak intensity for 30 seconds, stimulate for 60 seconds and ramp down for 30 seconds, which mimics the sensation of actual tACS stimulation and improves blinding.The sham-tACS will be delivered via a transcranial electrical stimulation (tES) device (Nurostym tES, Brainbox Ltd, United Kingdom). This device has been CE-marked for use as a medical device for the treatment of mental and neurological disorders.
| Study group | Role | What they receive |
|---|---|---|
| Standardized treatment arm | Experimental | Standardized tACS will be applied with 2.0 mA (peak-to-peak) intensity for 30 minutes, with a 10 Hz frequency. Two 5x5 cm saline-soaked electrodes located at the frontal and occipito-parietal part of the scalp will be utilized (corresponding to 10-20 EEG electrode locations POz-Oz and AFz), including in the stimulation field the DLPFC, precuneus and posterior cingulate cortex. At the beginning of stimulation, the intensity will ramp up for 30 seconds to 2.0 mA peak-to-peak, while at the end of stimulation, the intensity will ramp down for 30 seconds. Receives: Device: transcranial alternating current stimulation (tACS) |
| Personalized treatment arm | Experimental | Personalized tACS will be applied with 2.0 mA (peak-to-peak) intensity for 30 minutes with a 30 second ramp up and ramp down. Treatment will be personalized based on a delirium neural mass model. After fitting the model to the individual EEG, a virtual tACS trial allows for optimization of treatment parameters for each individual patient. Treatment optimization will take place through changing stimulation location and/or frequency. After determining the optimal individual treatment strategy, settings of the personalized stimulation will remain constant during the treatment phase. Receives: Device: transcranial alternating current stimulation (tACS) |
| Sham treatment arm | Sham comparator | At the beginning and end of this 30-minute protocol, the tACS device will ramp up to 2.0 mA peak-to-peak intensity for 30 seconds, stimulate for 60 seconds and ramp down for 30 seconds, which mimics the sensation of actual tACS stimulation and improves blinding. Receives: Device: Sham transcranial alternating current stimulation (tACS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative delta power
Calculated by dividing the absolute power in the delta frequency range by the total power, assessed using 64-channel resting-state EEG directly before and after tACS.
Measured: 1 day
Secondary outcomes (9)
Duration of delirium
Delirium duration is evaluated by counting the number of days delirium is observed during the treatment period. We utilize the Intensive Care Delirium Screening Checklist (ICDSC), comprising 8 items, with a score of 4 or higher indicating the presence of delirium. Additionally, the Richmond Agitation-Sedation Scale (RASS), a 10-point scale ranging from +4 to -5, is used to assess the level of sedation (-5 indicating total sedation, +4 indicating combative behavior). A RASS score of -4 or lower, followed by an ICDSC score of 4 or higher, is also considered a delirium day.
Measured: Two weeks
Severity of delirium
The cumulative score on the Intensive Care Delirium Screening Checklist (ICDSC), which includes 8 items and has a score range of 0-8, is documented for each day where delirium is observed during the hospital admission. In instances where the ICDSC score is unavailable, it will be approximated using information retrieved from the electronic patient record and standard delirium assessment tools routinely conducted.
Measured: Two weeks
Length of hospital stay
The total number of days admitted to hospital
Measured: 3 months
Cognitive status three months post delirium
Score on the Telephone Interview for Cognitive Status Modified (TICS-M). The TICS-M is a brief, 13-item test of cognitive functioning with scores ranging from 0 to 50, with higher scores indicating better cognitive performance.
Measured: 3 months
Subjective sensations during treatment
Score on three-point Likert-type scale to assess sensations experienced during transcranial alternating current stimulation (tACS). The scale ranged from 0, indicating 'no sensation,' to 1, indicating 'slight sensation,' and 2, indicating 'intense sensation.' These sensations included itch, pain, burning sensation, heat, iron taste, headache, neck pain, phosphenes, dizziness, and nausea.
Measured: Two weeks
Average peak frequency
Average peak frequency values will be calculated by averaging, over epochs, the peak frequency, assessed using 64-channel resting-state EEG before and after tACS and during the follow-up measurement.
Measured: Two weeks
Phase Lag Index
Phase lag index captures phase synchronization between different EEG channels, assessed using 64-channel resting-state EEG before and after tACS and during the follow-up measurement.
Measured: Two weeks
Corrected Amplitude Envelope Correlation (AECc)
AECc captures amplitude synchronization between different EEG channels, assessed using 64-channel resting-state EEG before and after tACS and during the follow-up measurement.
Measured: Two weeks
Relative power
Relative power will be calculated by dividing the absolute power of the frequency band by the total absolute power in the EEG, assessed using 64-channel resting-state EEG before and after tACS and during the follow-up measurement.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start24 Apr 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.J.C. Slooter
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, HagaZiekenhuis
- Responsible party
- Sponsor-investigator, A.J.C. Slooter, UMC Utrecht
- Investigators
- Arjen JC Slooter, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285721
- Sponsor's protocol ID
- DELTES
- Acronym
- DELTES
- Status last verified
- Jul 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patients can specify whether they agree to share their data with other research institutes. Depending on consent of participants, we might be able to share IPD after publication of results.
Publications
van der A J, Lodema DY, van Dellen E, Tendolkar I, Emmelot-Vonk MH, Schutter DJLG, de Haan W, van den Boogaard M, Ottens TH, Slooter AJC. Transcranial alternating current stimulation as treatment for delirium: A multicenter randomized double-blind sham-controlled pilot study on safety and feasibility. Neurotherapeutics. 2026 Aug 4;23(5):e01037. doi: 10.1016/j.neurot.2026.e01037. Online ahead of print.
PubMed 42551052van der A J, Lodema Y, Ottens TH, Schutter DJLG, Emmelot-Vonk MH, de Haan W, van Dellen E, Tendolkar I, Slooter AJC. DELirium treatment with Transcranial Electrical Stimulation (DELTES): study protocol for a multicentre, randomised, double-blind, sham-controlled trial. BMJ Open. 2024 Nov 2;14(11):e092165. doi: 10.1136/bmjopen-2024-092165.
PubMed 39488424
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DELirium Treatment With Transcranial Electrical Stimulation
- ClinicalTrials.gov ID
- NCT06285721
- Acronym / sponsor ID
- DELTES / DELTES
- Conditions
- Delirium
- Keywords
- electroencephalography, transcranial alternating current stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- A.J.C. SlooterUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, HagaZiekenhuis
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 29 Feb 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 investigate the effectiveness of standardized and personalized transcranial alternating current stimulation (tACS) in patients with delirium. To investigate this, will perform a double-blind, randomized, sham-controlled, multicenter trial.
To test the safety and feasibility of tACS in delirious patients, the first 30 patients will be randomized to receive either active or sham tACS treatment in a 1:1 ratio through a pilot study. For the main phase of the study, patients will be randomized, resulting in an overall 1:1:1 allocation to standardized tACS, personalized tACS or sham treatment.
Electroencephalogram (EEG) will be measured directly before and directly after the first stimulation session to assess whether tACS can reduce relative delta power. tACS or sham treatment will be given once daily for a maximum of 14 days, or until resolution of delirium or discharge (whichever comes first). During the treatment phase, presence and severity of delirium will be assessed daily. After the treatment phase, an additional EEG will be measured. Cognitive status will be assessed three months after the initial tACS session.
Detailed description
Delirium, a prevalent neuropsychiatric syndrome caused by an underlying medical condition, characterized by cognitive deficits such as inattention, extends hospital stay, increases healthcare costs and increases the risk of long-term cognitive decline. Prolonged and severe delirium is associated with worse long-term outcomes. There is currently no treatment that reduces the duration or severity of delirium.
Delirium is consistently characterized by diffuse oscillatory slowing of the EEG, including pronounced loss of alpha activity and increased relative delta power. Additionally, functional connectivity between brain regions is decreased during delirium. In light of this, tACS is a potential treatment option that directly addresses the brain dysfunction observed in delirium. Because tACS has shown the ability to improve multiple domains of cognition, including attention, and modify functional connectivity, we aim to investigate the effectiveness of tACS as treatment for delirium. We will utilize the EEG to measure the effects of tACS, using relative delta power as a primary outcome measure.
Additionally, EEG measurements can capture individual spectral and connectivity changes targeted with tACS, making EEG a promising input for personalized tACS treatment. Neural mass modelling is a way to model the behavior of groups of neurons resulting in oscillatory output similar to EEG. This type of model is able to represent delirium pathology and, when combined with individual EEG input, can be employed to optimize treatment effectiveness, leading to personalized tACS treatment.
The overarching aim of the study is to investigate whether treatment with tACS, either standardized or personalized, induces EEG alterations indicative of reversal of delirium. The primary outcome is relative delta power in the EEG measured after the first tACS session. Secondary outcomes include severity and/or duration of delirium measured with validated delirium assessment instruments.
Patients aged 50 years and older with delirium that persists for at least 2 days, despite adequate treatment of underlying causes will be included in the study (n = 159). Inclusion will take place in the intensive care unit (ICU) and non-ICU wards of the University Medical Centre (UMC) Utrecht, Radboud UMC and HagaZiekenhuis.The proposed tACS protocol is considered safe according to the latest published international safety guidelines. All participants will be screened for their relevant medical history and other tACS safety aspects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standardized treatment arm | Experimental | Device: transcranial alternating current stimulation (tACS)Standardized tACS will be applied with 2.0 mA (peak-to-peak) intensity for 30 minutes, with a 10 Hz frequency. Two 5x5 cm saline-soaked electrodes located at the frontal and occipito-parietal part of the scalp will be utilized (corresponding to 10-20 EEG electrode locations POz-Oz and AFz), including in the stimulation field the DLPFC, precuneus and posterior cingulate cortex. At the beginning of stimulation, the intensity will ramp up for 30 seconds to 2.0 mA peak-to-peak, while at the end of stimulation, the intensity will ramp down for 30 seconds. |
| Personalized treatment arm | Experimental | Device: transcranial alternating current stimulation (tACS)Personalized tACS will be applied with 2.0 mA (peak-to-peak) intensity for 30 minutes with a 30 second ramp up and ramp down. Treatment will be personalized based on a delirium neural mass model. After fitting the model to the individual EEG, a virtual tACS trial allows for optimization of treatment parameters for each individual patient. Treatment optimization will take place through changing stimulation location and/or frequency. After determining the optimal individual treatment strategy, settings of the personalized stimulation will remain constant during the treatment phase. |
| Sham treatment arm | Sham comparator | Device: Sham transcranial alternating current stimulation (tACS)At the beginning and end of this 30-minute protocol, the tACS device will ramp up to 2.0 mA peak-to-peak intensity for 30 seconds, stimulate for 60 seconds and ramp down for 30 seconds, which mimics the sensation of actual tACS stimulation and improves blinding. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 50 years.
- Diagnosis of delirium
- Richmond Agitation and Sedation Scale (RASS) score of -2 to +2.
- Delirium duration of at least two days prior to study inclusion, based delirium assessments and/or descriptions in the medical and/or nursing files.
- Known causes underlying delirium are being treated adequately, as assessed by the treating physician.
Key exclusion criteria (10 listed)
- Inability to conduct delirium assessment (e.g. coma, deaf, blind) or inability to speak Dutch or English.
- A moribund state.
- Alcohol/substance abuse withdrawal or stroke as precipitating factor for delirium.
- Diagnosis of dementia, based on medical record review and/or a score of ≥4.5 on the short form of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
- One or more contra-indications for tACS:
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)tACS is a non-invasive brain stimulation technique which involves the application of a low intensity electric current between two or more surface electrodes. tACS uses stimulation with a current alternating at a specific frequency that can entrain endogenous neuronal oscillations by inducing neural synchronization. The administration of tACS is proposed to phase-lock large populations of neurons in the superficial layers of the cerebral cortex causing neural synchronization in the corresponding frequency, thereby altering connectivity. tACS will be delivered via a transcranial electrical stimulation (tES) device (Nurostym tES, Brainbox Ltd, United Kingdom). This device has been CE-marked for use as a medical device for the treatment of mental and neurological disorders. | Device | Personalized treatment arm, Standardized treatment arm |
| Sham transcranial alternating current stimulation (tACS)Sham-tACS is a form of non-effective stimulation which can mimic the subjective sensation of active tACS treatment. During sham-tACS, the device will ramp up to 2.0 mA peak-to-peak intensity for 30 seconds, stimulate for 60 seconds and ramp down for 30 seconds, which mimics the sensation of actual tACS stimulation and improves blinding.The sham-tACS will be delivered via a transcranial electrical stimulation (tES) device (Nurostym tES, Brainbox Ltd, United Kingdom). This device has been CE-marked for use as a medical device for the treatment of mental and neurological disorders. | Device | Sham treatment arm |
Primary outcome
Relative delta power
Time frame: 1 day
Calculated by dividing the absolute power in the delta frequency range by the total power, assessed using 64-channel resting-state EEG directly before and after tACS.
9 secondary outcomes
Duration of delirium
Time frame: Two weeks
Severity of delirium
Time frame: Two weeks
Length of hospital stay
Time frame: 3 months
Cognitive status three months post delirium
Time frame: 3 months
Subjective sensations during treatment
Time frame: Two weeks
Average peak frequency
Time frame: Two weeks
Phase Lag Index
Time frame: Two weeks
Corrected Amplitude Envelope Correlation (AECc)
Time frame: Two weeks
Relative power
Time frame: Two weeks
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 26 Jul 2024.
- Derived from this study: PubMed 42551052van der A J, Lodema DY, van Dellen E, Tendolkar I, Emmelot-Vonk MH, Schutter DJLG, de Haan W, van den Boogaard M, Ottens TH, Slooter AJC. Transcranial alternating current stimulation as treatment for delirium: A multicenter randomized double-blind sham-controlled pilot study on safety and feasibility. Neurotherapeutics. 2026 Aug 4;23(5):e01037. doi: 10.1016/j.neurot.2026.e01037. Online ahead of print.
- Derived from this study: PubMed 39488424van der A J, Lodema Y, Ottens TH, Schutter DJLG, Emmelot-Vonk MH, de Haan W, van Dellen E, Tendolkar I, Slooter AJC. DELirium treatment with Transcranial Electrical Stimulation (DELTES): study protocol for a multicentre, randomised, double-blind, sham-controlled trial. BMJ Open. 2024 Nov 2;14(11):e092165. doi: 10.1136/bmjopen-2024-092165.
- Individual participant dataSharing planned: Yes. Patients can specify whether they agree to share their data with other research institutes. Depending on consent of participants, we might be able to share IPD after publication of results.
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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.
Arjen JC Slooter, MD, PhD principal investigator
UMC Utrecht
2 sites 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 A.J.C. Slooter at 2 sites in Netherlands.
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 5 inclusion and 10 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 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 Yorben Lodema, MD (088 7558300, deltes@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative delta power (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06285721, which also lists 2 linked publications.
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 26 Jul 2024.