Primary Objective: Testing the efficacy of tDCS as a 7 day add-on prevention in patients electively admitted to the ICU after cardiothoracic surgery on top of usual clinical care by measuring the change in delirium symptoms.Secondary Objective(s):…
ID
Source
Brief title
Condition
- Deliria (incl confusion)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Efficacy to use tDCS as preventive treatment for delirioum ( as measured with
clinical scales) in patients admitted to the ICU electively or acutely after
cardiothoracic surgery. tDCS is applied on top of routine clinical care.
Secondary outcome
- Cognitive symptoms at baseline in elective patients and after one week
intervention will be assessed by the Montreal Cognitive Assessment Scale (MOCA,
for a direct comparison also with the Mini mental state examination see
Saczynsky et al., 2016).
- Effect on incidence of delirium and delirium symptoms will be compared with a
comparable anonymized dataset of cardiothoracic patients matched on age and
co-morbidity (Charlson Index).
- Feasibility to apply tDCS in patients that develop delirium.
- Moreover feasibility is measured defined as the degree to which tDCS sessions
are completed. Also, patients and tDCS staff will use a 5-point Likert scale
to answer questions about practicality and burden.
Background summary
Delirium affects 20-30% of patients after cardiac surgery and is associated
with deleterious short term outcome and persistent cognitive decline. Delirium
signs may evolve already during postoperative stay of these patients on the
intensive care unit (ICU). Prevention of delirium post-cardiac surgery has
proven to be problematic. Non-pharmacological interventions to prevent
delirium on the ICU in post-cardiac surgery patients are limited as patients
are often elderly, deeply sedated, with multi-morbidity and polypharmacy.
Pharmacological treatment of delirium in ICU patients (antipsychotics,
benzodiazepines) did not proof to be effective.
Non-invasive brain stimulation in the form of transcranial direct current
stimulation (tDCS) has shown to alter brain oscillations thereby improving
neurocognitive capacity as can be measured in performance in attention, memory
and executive function. Currently tDCS is widely tested as add-on treatment
option in the field of neuropsychiatric rehabilitation. It seems therefore
worthwhile to investigate the feasibility and potential efficacy of tDCS in ICU
patients after cardiac surgery as tDCS is an non-invasive, painless and easy
to perform method of treatment witch modulates EEG patterns and hopefully
prevents or ameliorates the occurrence and course of delirium .
Study objective
Primary Objective: Testing the efficacy of tDCS as a 7 day add-on prevention
in patients electively admitted to the ICU after cardiothoracic surgery on top
of usual clinical care by measuring the change in delirium symptoms.
Secondary Objective(s): change in cognitive symptoms one week after
intervention. Feasibility reports of patients, ICU nurses and trained member of
the consultation psychiatry team (MP/IT or trained nurse).
Study design
Pilot open label study whereby 20 patients undergoing cardiothoracic surgery
including postoperative care at the ICU will receive an anodal treatment
(anodal electrode over left dorsolateral prefrontal cortex (DLPFC)) with tDCS
on 7 consecutive days , starting 1 or two days after the operation (depending
on the level of sedation). tDCS will be given by a medical specialist trained
in neuromodulation (IT/MP) who is supported by a nurse from the consultation
psychiatry service and a master student neuroscience. tDCS treatment will be
started at the ICU and continued at the ward where patients are usually
referred to,after three days. Treatment will be continued independent of
absence or presence of delirium symptoms. Delirium treatment will be performed
as usual. Change in delirium symptoms will be assessed with the intensive care
delirium checklist (ICDSC) on/at ? the ICU and the delirium observation scale
(DOS) on/at? the ward, during the cause of 10 days and the Montreal Cognitive
Assessment Scale (MOCA) will be assessed prior to surgery (if possible) and
after 7 days of tdcs treatment.
Intervention
Patients will receive a seven day stimulation (DC-Stimulator, NeuroConn GmbH,
Germany) consisting of 2 mA tDCS delivered for 20 minutes using a pair of
electrodes with conductive paste (surface 35 cm2, current density ±0.03
mA/cm2). The anode will be placed over the left dorsolateral prefrontal cortex.
The cathode will be placed over the right supraorbital area.
Study burden and risks
tDCS is a widely used non-invasive neuromodulation technique, applying weak
direct currents through conductive rubber/sponge electrodes to the scalp. These
weak currents can slightly shift the neurons* membrane potential and thereby
modulate spontaneous neuronal activity in the stimulated cortex. During
stimulation, participants may transiently experience light tingling or itching
sensations on the skin underlying the electrodes. which can be unpleasant. The
most common side-effects are a light transient headache and a feeling of
fatigue. The conventional tDCS protocol proposed here is considered safe
according to the latest published international safety guidelines. All
participants are screened for their relevant medical history and other tDCS
safety aspects (e.g. metal parts in the head, skin allergies). In summary, the
tDCS risk is negligible, the burden associated with participation can be
considered minimal, and no serious adverse events are expected during this
study as a result of the tDCS intervention. Patients can withdraw from the
study at any time. Delirium is a burden for patient and family of the patient
and particular at the ICU effective treatment is a matter of debate. Even small
improvements in prevention of treatment of delirium will therefore have large
clinical and societal impact.
Reinier Postlaan 10
Nijmegen 6500 HB
NL
Reinier Postlaan 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
Admitted acutely or electively to the adult ICU of the Radboudumc following
cardiothoracic surgery. From this group, we suggest to only select the
cardiothoracic surgery adult patients with the highest incidence of
post-operative delirium (30-50%). These include those that undergo the
following types of surgery: all aortic surgery, CABG combined with valve
surgery, double valve surgery.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
History of dementia
Inability to conduct valid delirium screening assessment (e.g. coma, deaf,
blind, severe polyneuropathy or myopathy) or inability to speak the Dutch
language.
Epilepsy
Known pre-existing dementia
Standard contra-indications for tDCS, including:
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 at intended electrode sites
Expected to die within 24*hours.
On top of these exclusion criteria, there are specific reasons why a tDCS
session cannot be performed, including:
* RASS score of -3 or lower
* Severe agitation (RASS >+2)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76704.091.21 |