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Early Neurocognitive Rehabilitation in Intensive Care (ENRIC)

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Neurocognitive stimulation
Sponsored by
Corporacion Parc Tauli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Critical illness, Neurocognition, Neurocognitive stimulation, Delirium, Virtual Reality, cognitive, rehabilitation, ICU

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Corporació Parc Taulí

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Neurocognitive stimulation

Treatment as usual

Arm Description

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.

Outcomes

Primary Outcome Measures

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)
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)
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)
Speed processing
- Information processing speed: Symbol Search subtest of the WAIS III (Wechsler, 1999)
Psychopathological status
Depression: Hamilton Depression Rating Scale (HDRS) (Hamilton, 1960) Anxiety: Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959)
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)

Secondary Outcome Measures

Delirium
Number of episodes and duration of delirium: Confusional Assessment Method for Intensive Care Unit (CAM-ICU)

Full Information

First Posted
February 28, 2014
Last Updated
March 8, 2022
Sponsor
Corporacion Parc Tauli
Collaborators
Fundació La Marató de TV3
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1. Study Identification

Unique Protocol Identification Number
NCT02078206
Brief Title
Early Neurocognitive Rehabilitation in Intensive Care
Acronym
ENRIC
Official Title
Early Neurocognitive Rehabilitation in Intensive Care
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli
Collaborators
Fundació La Marató de TV3

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Critical illness, Neurocognition, Neurocognitive stimulation, Delirium, Virtual Reality, cognitive, rehabilitation, ICU

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurocognitive stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Neurocognitive stimulation
Primary Outcome Measure Information:
Title
Attention
Description
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)
Time Frame
Hospital discharge and 3-months after hospital discharge
Title
Memory
Description
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)
Time Frame
Hospital discharge and 3-months after hospital disharge
Title
Executive Functions
Description
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)
Time Frame
Hospital discharge and 3-months after hospital discharge
Title
Speed processing
Description
- Information processing speed: Symbol Search subtest of the WAIS III (Wechsler, 1999)
Time Frame
Hospital discharge and 3-months after hospital discharge
Title
Psychopathological status
Description
Depression: Hamilton Depression Rating Scale (HDRS) (Hamilton, 1960) Anxiety: Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959)
Time Frame
Hospital discharge and 3-monts after hospital discharge
Title
Functional Status
Description
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)
Time Frame
hospital discharge and 3-months after hospital discharge
Secondary Outcome Measure Information:
Title
Delirium
Description
Number of episodes and duration of delirium: Confusional Assessment Method for Intensive Care Unit (CAM-ICU)
Time Frame
Every day during ICU stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lluis Blanch, Phd
Organizational Affiliation
Fundació Parc Taulí
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoni Artigas, Phd
Organizational Affiliation
Corporació Parc Taulí- Critical Care Unit chair
Official's Role
Study Director
Facility Information:
Facility Name
Corporació Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
28770543
Citation
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.
Results Reference
derived

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Early Neurocognitive Rehabilitation in Intensive Care

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