ENRIC: Early Neurocognitive Rehabilitation in Intensive Care

Sponsor

Corporacion Parc Tauli (Other)

Overall Status

Completed

CT.gov ID

NCT02078206

Collaborator

Fundació La Marató de TV3 (Other)

Enrollment

Location

Arms

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness	Other: Neurocognitive stimulation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Early Neurocognitive Rehabilitation in Intensive Care

Actual Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Jul 1, 2020

Actual Study Completion Date :

Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neurocognitive stimulation 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
No Intervention: Treatment as usual

Arm

Intervention/Treatment

Experimental: Neurocognitive stimulation

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

No Intervention: Treatment as usual

Outcome Measures

Primary Outcome Measures

Attention [Hospital discharge and 3-months after hospital discharge]
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)
Memory [Hospital discharge and 3-months after hospital disharge]
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)
Executive Functions [Hospital discharge and 3-months after hospital discharge]
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)
Speed processing [Hospital discharge and 3-months after hospital discharge]
- Information processing speed: Symbol Search subtest of the WAIS III (Wechsler, 1999)
Psychopathological status [Hospital discharge and 3-monts after hospital discharge]
Depression: Hamilton Depression Rating Scale (HDRS) (Hamilton, 1960) Anxiety: Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959)
Functional Status [hospital discharge and 3-months after hospital discharge]
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)

Secondary Outcome Measures

Delirium [Every day during ICU stay]
Number of episodes and duration of delirium: Confusional Assessment Method for Intensive Care Unit (CAM-ICU)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.