Critical IllnessENRICNCT02078206
Early Neurocognitive Rehabilitation in Intensive Care
A study testing Neurocognitive stimulation in people with Critical Illness, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Neurocognitive stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2015to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Neurocognitive stimulation
- Keywords
- Critical illness, Neurocognition, Neurocognitive stimulation, Delirium, Virtual Reality, cognitive, rehabilitation, ICU
- Medical subject headings
- Critical Illness, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive stimulationOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Neurocognitive stimulation |
| Treatment as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: Hospital discharge and 3-months after hospital discharge
Speed processing
- Information processing speed: Symbol Search subtest of the WAIS III (Wechsler, 1999)
Measured: 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)
Measured: 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)
Measured: hospital discharge and 3-months after hospital discharge
Secondary outcomes (1)
Delirium
Number of episodes and duration of delirium: Confusional Assessment Method for Intensive Care Unit (CAM-ICU)
Measured: Every day during ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startNov 2015
- Primary completionJul 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació La Marató de TV3
- Responsible party
- Principal investigator, Lluis Blanch, Corporacion Parc Tauli
- Investigators
- Lluis Blanch, Phd, Principal investigator, Fundació Parc TaulíAntoni Artigas, Phd, Study director, Corporació Parc Taulí- Critical Care Unit chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078206
- Sponsor's protocol ID
- FPT-2013/057
- Acronym
- ENRIC
- Status last verified
- Mar 2022
- First submitted
- 28 Feb 2014
- Last updated
- 9 Mar 2022
- Results posted
- No
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.
PubMed 28770543
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Neurocognitive Rehabilitation in Intensive Care
- ClinicalTrials.gov ID
- NCT02078206
- Acronym / sponsor ID
- ENRIC / FPT-2013/057
- Conditions
- Critical Illness
- Keywords
- Critical illness, Neurocognition, Neurocognitive stimulation, Delirium, Virtual Reality, cognitive, rehabilitation, ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Fundació La Marató de TV3
- Study start
- Nov 2015 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurocognitive stimulation | Experimental | Other: Neurocognitive stimulationIntervention 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. |
| Treatment as usual | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurocognitive stimulation | Other | Neurocognitive stimulation |
Primary outcome
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)
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)
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)
Speed processing
Time frame: Hospital discharge and 3-months after hospital discharge
- Information processing speed: Symbol Search subtest of the WAIS III (Wechsler, 1999)
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)
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)
1 secondary outcome
Delirium
Time frame: Every day during ICU stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Derived from this study: PubMed 28770543Turon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lluis Blanch, Phd principal investigator
Fundació Parc Taulí
Antoni Artigas, Phd study director
Corporació Parc Taulí- Critical Care Unit chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurocognitive stimulation in people with Critical Illness, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention (time frame: Hospital discharge and 3-months after hospital discharge). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02078206, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.