Early Neurocognitive Rehabilitation in Intensive Care (ENRIC)

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Other: Neurocognitive stimulation

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporació Parc Tauli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as usual
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Collaborators: Fundació La Marató de TV3
• Investigators: Principal Investigator: Lluis Blanch, Phd, Fundacio Parc Tauli; Study Director: Antoni Artigas, Phd, Corporació Parc Taulí- Critical Care Unit chair

Publications and helpful links

General Publications

• Turon M, Fernandez-Gonzalo S, Jodar M, Goma G, Montanya J, Hernando D, Bailon R, de Haro C, Gomez-Simon V, Lopez-Aguilar J, Magrans R, Martinez-Perez M, Oliva JC, Blanch L. Feasibility and safety of virtual-reality-based early neurocognitive stimulation in critically ill patients. Ann Intensive Care. 2017 Dec;7(1):81. doi: 10.1186/s13613-017-0303-4. Epub 2017 Aug 2.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: February 28, 2014
• First Submitted That Met QC Criteria: March 3, 2014
• First Posted (Estimate): March 5, 2014

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: rehabilitation; ICU; Virtual Reality; Critical illness; Delirium; Neurocognition; cognitive; Neurocognitive stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: FPT-2013/057