Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT06285721

Delirium Treatment With Transcranial Electrical Stimulation

Led by A.J.C. Slooter · Updated on 2024-07-26

159

Participants Needed

2

Research Sites

153 weeks

Total Duration

On this page

Sponsors

A

A.J.C. Slooter

Lead Sponsor

R

Radboud University Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Delirium Treatment With Transcranial Electrical Stimulation

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 50 years.
  • Diagnosis of delirium.
  • Richmond Agitation and Sedation Scale (RASS) score between -2 and +2.
  • Delirium lasting at least two days prior to inclusion.
  • Adequate treatment of known causes of delirium as assessed by the physician.
Not Eligible

You will not qualify if you...

  • Inability to conduct delirium assessment (e.g., coma, deafness, blindness) or inability to speak Dutch or English.
  • Being in a moribund state.
  • Alcohol or substance withdrawal or stroke causing delirium.
  • Diagnosis of dementia or a score of 4.5 or higher on the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE).
  • Contraindications for tACS including:
    1. History of serious head trauma or brain surgery;
    2. Large or ferromagnetic metal parts in the head (except dental wire);
    3. Implanted cardiac pacemaker or neurostimulator;
    4. Skin diseases or inflammations;
    5. Epilepsy.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Radboudumc

Nijmegen, Gelderland, Netherlands, 6525 GA

Actively Recruiting

2

HagaZiekenhuis

The Hague, South Holland, Netherlands, 2545 AA

Actively Recruiting

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Research Team

Y

Yorben Lodema, MD

CONTACT

J

Julia van der A, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Delirium Treatment With Transcranial Electrical Stimulation | DecenTrialz