Early Neurocognitive Rehabilitation in Intensive Care

Study Overview
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Brief Summary
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The purpose of this project is to assess the efficacy of an early neurocognitive intervention for ICU patients, in terms of psychopathological, neuropsychological and functional improvement. The treatment is supported in an interactive advanced computing platform that includes the continuous biomedical registration of the patients and a virtual reality software specifically designed for critical patients. The investigators expect an improvement in neuropsychological, psychopathological and functional status at hospital discharge and 3 months follow-up in those patients that have received the early neurocognitive intervention comparing with patients treated as usual. Furthermore the investigators expect a decrease of episodes and/or duration of delirium in ICU patients.

Official Title
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Early Neurocognitive Rehabilitation in Intensive Care

Conditions
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Critical Illness

Intervention / Treatment
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* Other: Neurocognitive stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 18 and 80 years Patients receiving mechanical ventilation for at least 24 hours Patients scoring more than 8 on the Glasgow Coma Scale (GCS) and more than 2 on the Sedation Agitation Scale (SAS) Patients haemodynamically stable Informed consent signed by the closest relatives. Exclusion Criteria: Patients with previous neurologic pathology or focal brain injury before ICU admission Patients with serious psychiatric pathology (major depression, psychosis, bipolar disease) or mentally retarded Patients with sensorial alterations needed to interact with the neurocognitive stimulation programme patients whose closest relatives refuse the subject to be included in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurocognitive stimulation<br>Intervention of experimental group consists in a neurocognitive stimulation treatment. Using kinect technology, patient can interact with a virtual environment where different cognitive tasks have to be resolved. | Other: Neurocognitive stimulation<br> <br> |
| No Intervention: Treatment as usual<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attention | Verbal attention: Digits Forward subtest of the WAIS III (Wechsler, 1999) Visual attention: Spatial Localization Forward subtest of the WMS III (Wechsler, 1999) Sustained/Selective attention: Continuous Performance Test (Conners, 1992) | Hospital discharge and 3-months after hospital discharge | 
| Memory | Verbal learning and memory: Auditory Verbal Learning Test (Rey, 1964) Visual learning and memory: 10/36 Spatial Recall Test (Rao, 1992) Visual recognition: Benton Visual Retention Test (Benton, 1983) | Hospital discharge and 3-months after hospital disharge | 
| Executive Functions | Stimuli alternation and sequencing: Trail Making Test A-B (Mimeo & Manga, 1999) Automatic inhibition response: Stroop Test (Golden & Charles, 1978) Visual planning: Tower of London (Shallice, 1982). Phonetic verbal fluency: FAS test (Spreen and Benton, 1995) Semantic verbal fluency: Animals 1' (Benton & Hamsher, 1976) | Hospital discharge and 3-months after hospital discharge | 
| Speed processing | - Information processing speed: Symbol Search subtest of the WAIS III (Wechsler, 1999) | Hospital discharge and 3-months after hospital discharge | 
| Psychopathological status | Depression: Hamilton Depression Rating Scale (HDRS) (Hamilton, 1960) Anxiety: Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) | Hospital discharge and 3-monts after hospital discharge | 
| Functional Status | Quality of life questionnaire: Satisfaction and Pleasure (Q-LES-Q) (Endicott, J., Nee, J., Harrison, W. & Blumenthal, R., 1993) Lawton and Brody Functional Scale (1969) | hospital discharge and 3-months after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium | Number of episodes and duration of delirium: Confusional Assessment Method for Intensive Care Unit (CAM-ICU) | Every day during ICU stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical illness, Neurocognition, Neurocognitive stimulation, Delirium, Virtual Reality, cognitive, rehabilitation, ICU