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Piloting the effect of transcranial direct current stimulation(tDCS) in the prevention and treatment of delirium in patients undergoing cardiothoracal surgery

Piloting the effect of transcranial direct current stimulation(tDCS) in the prevention and treatment of delirium in patients undergoing cardiothoracal surgery - tDCS in delirium patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51005
Enrollment
20
Registered
2021-05-12
Start date
2021-06-08
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

confusion delirium

Interventions

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 c

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)