acute encephalopathy delirium
Conditions
Interventions
Patients will receive tACS consisting of 2 mA (peak-to-peak) stimulation
delivered for 30 minutes, using two 5x5 cm electrodes placed under a standard
64-channel EEG cap, for a maximum of 14 days. F
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: Inability to conduct valid delirium screening assessment (e.g. coma, deaf, blind) or inability to speak the Dutch or English language. Patients in 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). Standard 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the effects of tACS treatment on delirium, our two primary objectives are as follows: I. To investigate whether one session of standardized tACS reduces the relative delta power observed in delirium, measured using EEG. II. To investigate whether one session of personalized tACS, based on a computational model and virtual trial using EEG as input, reduces the relative delta power in patients with delirium, measured using EEG. The two main objectives of the study share the same outcome variable, namely relative delta power, measured immediately before and after the application of tACS or sham stimulation using a 64-channel EEG. Relative delta power has been chosen as the primary study parameter because delirium is consistently associated with increased delta EEG activity. As oscillatory synchronization can have cross-frequency effects, we hypothesize that tACS applied within the alpha frequency range improves functional connectivity, leading to reduced relative delta power. | — |
Secondary
| Measure | Time frame |
|---|---|
| The aim of the pilot study is to investigate whether the tACS treatment can be safely applied to, and tolerated sufficiently by, patients with delirium. Outcome measures include: the percentage of completed first stimulation sessions, increase in care needs within the first hour after tACS, and duration of delirium. Secondary outcomes of the main study include: severity of delirium, duration of delirium, length of hospitalization, cognitive ability three months after tACS treatment, difference in effect between standardized and personalized tACS, changes in power and functional connectivity measured using EEG, subjective expectations and evaluations of tACS as a treatment for delirium and the effect of cumulative tACS sessions. | — |
Countries
Germany, Netherlands
Contacts
Public ContactA.J.C. Slooter
Universitair Medisch Centrum Utrecht
Outcome results
None listed