DELirium Treatment With Transcranial Electrical Stimulation

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Radboudumc
RECRUITING
Nijmegen
HagaZiekenhuis
RECRUITING
The Hague
Contact Information
Primary
Yorben Lodema, MD
deltes@umcutrecht.nl
088 7558300
Backup
Julia van der A, MSc
j.vandera-2@umcutrecht.nl
088 756 7523
Time Frame
Start Date: 2024-04-24
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 159
Treatments
Experimental: Standardized treatment arm
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.
Experimental: Personalized treatment arm
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_comparator: Sham treatment arm
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.
Related Therapeutic Areas
Sponsors
Collaborators: HagaZiekenhuis, Radboud University Medical Center
Leads: A.J.C. Slooter

This content was sourced from clinicaltrials.gov