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Completed

NCT Number: NCT02078206

Early Neurocognitive Rehabilitation in Intensive Care

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corporació Parc Taulí

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurocognitive stimulation

Other

Primary outcomes

  1. Attention

    Time frame: 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)

  2. Memory

    Time frame: 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)

  3. Executive Functions

    Time frame: 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)

  4. Speed processing

    Time frame: Hospital discharge and 3-months after hospital discharge

    • Information processing speed: Symbol Search subtest of the WAIS III (Wechsler, 1999)

  5. Psychopathological status

    Time frame: 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)

  6. Functional Status

    Time frame: 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 outcomes

  1. Delirium

    Time frame: Every day during ICU stay

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

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Collaborators

  • Fundació La Marató de TV3

Registry information

Acronym: ENRIC

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2014
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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