Delirium Treatment With Transcranial Electrical Stimulation
DELTES
DELirium Treatment With Transcranial Electrical Stimulation
1 other identifier
interventional
159
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2024
CompletedFirst Posted
Study publicly available on registry
February 29, 2024
CompletedStudy Start
First participant enrolled
April 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
July 26, 2024
July 1, 2024
2.8 years
February 19, 2024
July 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 day
Secondary Outcomes (9)
Duration of delirium
Two weeks
Severity of delirium
Two weeks
Length of hospital stay
3 months
Cognitive status three months post delirium
3 months
Subjective sensations during treatment
Two weeks
- +4 more secondary outcomes
Study Arms (3)
Standardized treatment arm
EXPERIMENTALStandardized 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
EXPERIMENTALPersonalized 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 COMPARATORAt 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.
Interventions
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-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.
Eligibility Criteria
You may qualify if:
- Age over 50 years.
- Diagnosis of delirium
- Richmond Agitation and Sedation Scale (RASS) score of -2 to +2.
- Known causes underlying delirium are being treated adequately, as assessed by the treating physician.
You may not qualify if:
- 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;
- Large or ferromagnetic metal parts in the head (except for a dental wire);
- Implanted cardiac pacemaker or neurostimulator;
- Skin diseases or inflammations;
- Epilepsy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- A.J.C. Slooterlead
- Radboud University Medical Centercollaborator
- HagaZiekenhuiscollaborator
Study Sites (2)
Radboudumc
Nijmegen, Gelderland, 6525 GA, Netherlands
HagaZiekenhuis
The Hague, South Holland, 2545 AA, Netherlands
Related Publications (1)
van 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.
PMID: 39488424DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arjen JC Slooter, MD, PhD
UMC Utrecht
Central Study Contacts
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 INVESTIGATOR
- PI Title
- Professor of Intensive Care Neuropsychiatry
Study Record Dates
First Submitted
February 19, 2024
First Posted
February 29, 2024
Study Start
April 24, 2024
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
July 26, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After first published results, no end date
- Access Criteria
- After approval of the consortium members
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.