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Early Neurocognitive Rehabilitation in Intensive Care

Early Neurocognitive Rehabilitation in Intensive Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02078206
Acronym
ENRIC
Enrollment
72
Registered
2014-03-05
Start date
2015-11-30
Completion date
2020-09-30
Last updated
2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

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

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.

Interventions

OTHERNeurocognitive stimulation

Sponsors

Fundació La Marató de TV3
CollaboratorOTHER
Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Executive FunctionsHospital 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)
AttentionHospital 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)
MemoryHospital 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)
Functional Statushospital 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)
Speed processingHospital discharge and 3-months after hospital discharge\- Information processing speed: Symbol Search subtest of the WAIS III (Wechsler, 1999)
Psychopathological statusHospital discharge and 3-monts after hospital discharge* Depression: Hamilton Depression Rating Scale (HDRS) (Hamilton, 1960) * Anxiety: Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959)

Secondary

MeasureTime frameDescription
DeliriumEvery day during ICU stayNumber of episodes and duration of delirium: Confusional Assessment Method for Intensive Care Unit (CAM-ICU)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026