Early Neurocognitive Rehabilitation in Intensive Care

NCT02078206 | Completed

• 1 other identifier: FPT-2013/057
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

Critical illness; Neurocognition; Neurocognitive stimulation; Delirium; Virtual Reality; cognitive; rehabilitation; ICU

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Delirium

  Every day during ICU stay

Study Arms (2)

Neurocognitive stimulation

EXPERIMENTAL

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

Treatment as usual

NO INTERVENTION

Interventions

Neurocognitive stimulation OTHER

Neurocognitive stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Fundació La Marató de TV3: collaborator

Study Sites (1)

Corporació Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (1)

• 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.

  PMID: 28770543 DERIVED

MeSH Terms

Conditions

Critical Illness; Delirium

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lluis Blanch, Phd

  Fundació Parc Taulí

  PRINCIPAL INVESTIGATOR

• Antoni Artigas, Phd

  Corporació Parc Taulí- Critical Care Unit chair

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 5, 2014
• Study Start: November 1, 2015
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2020
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

ES (1)