Cognitive DysfunctionNCT02747784
Evaluation to Assess Cognitive Training for the Prevention of Post-operative Cognitive Decline
A study testing Cognitive training program RehaCom® in people with Cognitive Dysfunction, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this open, monocentric randomized, parallel-group, controlled trial is to compare two different computer-based cognitive training programs regarding the efficacy to prevent the 3-months incidence of postoperative cognitive dysfunction in female patients after elective urogynecological or breast cancer… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- Cognitive training program RehaCom®
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jul 2017to 28 Sep 2018
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pilot study: Female patients undergoing urogynecological or breast cancer surgery, screened at the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany
- Age 18 years or older
- Montreal Cognitive Assessment Score (MOCA) > 25
- Patient has access to Personal computer or Laptop with system software Windows XP Service Pack 3 (or newer); tablets or smart phones cannot by used.
- Written informed consent to participate after having been properly instructed
- Written informed consent that accidental clinically relevant diagnostic findings of MRI assessment are reported to the general practitioner of the patient
- Sufficient health insurance to cover additional diagnostic assessments in case of an accidental clinically relevant diagnostic finding of MRI assessment
- 24 female surgical control subjects from the POCD Register (EA1/104/169) and 24 female non-surgical control subjects
Who cannot join
- Apparent dementia
- Lacking willingness to take part in the study, or to have relevant study data collected, saved and analyzed for the purpose of the study
- Lacking willingness to be contacted by telephone or mail.
- Accommodation in an institution due to an official or judicial order
- Insufficient knowledge of German language
- Members of the hospital staff
Show all 16Show fewer
- Admitted in police custody
- Homelessness or other conditions that disable reachability for postoperative assessment by post or telephone
- Illiteracy
- Severe hearing impairment that affects the neuropsychological testing.
- Severe visual impairment that affects the neuropsychological testing.
- Participation in other prospective clinical interventional trials
- Daltonism
- Contra-indications against MRI assessment (claustrophobia, metallic implants, cardiac pacemaker, tatoos)
- Motor impairment that affects the use of a computer
- Regular use of psychotropic drugs (including sleep-inducing drugs and benzodiazepines) and substances which affect cognitive performance Control group
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin
Berlin, 13353
About this study
Official title: Randomized Evaluation to Assess Cognitive Training for the Prevention of Post-operative Cognitive Decline (REACT) - a Pilot Study
The purpose of this open, monocentric randomized, parallel-group, controlled trial is to compare two different computer-based cognitive training programs regarding the efficacy to prevent the 3-months incidence of postoperative cognitive dysfunction in female patients after elective urogynecological or breast cancer surgery.
Read the detailed description
The REACT trial has been designed as a feasibility study to investigate the impact of pre-, peri-, and postoperative computerized cognitive trainings on the incidence of postoperative cognitive dysfunction. Two different study groups (training programs) will be compared. Each group consists of two training modules of the validated computer based training program of cognitive functioning called RehaCom®. The experimental group consists of the modules 'Topological Memory (MEMO)' and 'Divided Attention 2 (GEA2)'. The active comparator group consists of the modules 'Topological Memory (MEMO)' and 'Working memory (WOME)'. 48 surgical patients undergoing elective urogynecological or breast cancer surgery will preoperatively be randomly assigned to one of two study groups. Before starting the training, patients will complete a neuropsychological test battery comprising the cognitive tests to measure POCD. The tests will be assessed at preoperative baseline visit and at 3-months follow-up. In order to correct change in cognitive performance for practice effects, a group of 24 female surgical control subjects will also prospectively be tested with the cognitive test battery at baseline and 3-months follow-up. The control subjects will be matched to the 2 study groups regarding health status, surgery and age, but will neither undergo the computerized cognitive training program RehaCom®. Further, 24 female control subjects are included from the POCD-Register (EA1/104/16) and will be matched to the 2 study groups as well.
After baseline assessment, the study group patients will be taught to use the training program RehaCom®, and training should start preoperatively as early as possible. The patients are recommended to perform the training daily during inpatient hospital stay, and at least three times a week for 30 to 60 minutes until month 3.
The neuropsychological assessment will be performed at preoperative baseline and at three-months follow-up. Postoperative cognitive dysfunction (POCD) will be classified using the dichotomous approach established by Rasmussen et al in the International Study on postoperative cognitive deficits (ISPOCD) (Rasmussen et al. The assessment of postoperative cognitive function. Acta Anaesthesiol Scand. 2001 Mar;45(3):275-89.) This calculation method defines POCD as a reliable change in pre- and postoperative cognitive performance (difference scores) of each individual in the surgical patients cohort as compared to the changes in a non-surgical control group (reliable change index in either a composite score including cognitive test parameters from all tests in the cognitive test battery or in at least two of the chosen cognitive test parameters).
Secondary outcome measures of this trial comprise structural and functional MRI measures, Electroencephalogram simultaneous with fMRI, intraoperative cerebral oximetry and neuromonitoring, delirium, pain, sleep quality, postoperative complications, frailty, psychological distress, quality of life, training performance and evaluation of the training.
- Conditions
- Cognitive Dysfunction
- Being tested
- Cognitive training program RehaCom®
- Keywords
- cognitive dysfunction, cognitive training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive training program RehaCom®Behavioural
Cognitive training program RehaCom®
| Study group | Role | What they receive |
|---|---|---|
| Study group experimental | Experimental | 24 female patients aged 18 years or older undergoing urogynecological or breast cancer surgery; the patients are recommended to perform the RehaCom® training modules 'Topological Memory (MEMO)' and 'Divided Attention 2 (GEA2)' daily during inpatient hospital stay, and at least three times a week for 30 to 60 minutes until month 3. Receives: Behavioral: Cognitive training program RehaCom® |
| Study group active comparator | Active comparator | 24 female patients aged 18 years or older undergoing urogynecological or breast cancer surgery; the patients are recommended to perform the RehaCom® training modules 'Topological Memory (MEMO)' and 'Working memory (WOME)' daily during inpatient hospital stay, and at least three times a week for 30 to 60 minutes until month 3. Receives: Behavioral: Cognitive training program RehaCom® |
| Control group | No intervention | 48 female control subjects aged 18 years or older (24 without surgery, 24 with urogynecological or breast cancer surgery) with a similar health status and age as the study group patients (similar distribution in the American Society of Anaesthesiologists physical status classification and relevant co-morbidities, e.g. diabetes, coronary artery disease, hypertension and hyperlipidemia). The patients are analyzed to correct for learning effects of the cognitive assessment testings in the study groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative cognitive dysfunction (POCD)
Cognitive functioning will be measured with a battery of computerized neuropsychological tests, non-computerized and computer-based tests from the Cambridge Neuropsychological Test Automated Battery [CANTAB®]
Measured: Up to 3 months
Secondary outcomes (38)
Divided attention
Divided attention will be measured in the pilot study with the Test of Attentional Performance - Mobility version (TAP-M), subtests divided attention and distractibility.
Measured: Up to 3 months
Incidence of postoperative delirium
Postoperative delirium rate, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) and Chart Review
Measured: Up to 7 days
Intraoperative depth of sedation
Intraoperative depth of sedation will be monitored in the pilot study with changes in the pattern off EEG-raw data measured with the Masimo SedLine® brain function monitoring for Root®.
Measured: At time of surgery
Depth of sedation on the Intensive Care Unit
Depth of sedation will be measured in the pilot study with the Richmond Agitation Sedation Scale (RASS)
Measured: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Intraoperative cerebral oximetry
Intraoperative cerebral oximetry will be measured in the pilot study by near-infrared spectroscopy (NIRS) developed for the Masimo Root® monitor.
Measured: At time of surgery
Quality of sleep
Quality of sleep will be measured with the Insomnia Severity Index (ISI)
Measured: Up to 3 months
Anxiety
Perioperative anxiety will be measured with the Faces Anxiety Scale (FAS) during hospital stay.
Measured: Up to hospital discharge, an expected average of 7 days
Intensive care unit length of stay
Measured: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Hospital length of stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Evaluation of the cognitive training program RehaCom® by patient
The evaluation will be measured with single items concerning patients' subjective rating of the quality of the training program, at least once during the week
Measured: Up to 3 months
Performance of cognitive training units of the program RehaCom®
Data will be saved automatically by the computerized training program. The training performance will be measured as the highest level a patient has reached per training module, as well as number of mistakes within each level.
Measured: Up to 3 months
Duration of the cognitive training of the program RehaCom®
Data will be saved automatically by the computerized training program. Duration will be measured as minutes per session and total sum of minutes of all sessions.
Measured: Up to 3 months
Frequency of the cognitive training of the program RehaCom®
Data will be saved automatically by the computerized training program. Frequency will be measured as number of sessions and number of weeks with at least 1 session per week.
Measured: Up to 3 months
MRI assessment
Functional MRI: Changes in neural activations in temporal and fronto-parietal brain regions during recognition in a face-name association task at baseline and three months after baseline assessment
Measured: Up to 3 months
MRI assessment
Structural MRI: Changes in gray and white matter.
Measured: Up to 3 months
MRI assessment
Functional MRI: Changes in neural activations in temporal and fronto-parietal brain regions during memory encoding at baseline and three months after baseline assessment
Measured: Up to 3 months
Barthel Activities of Daily Living (ADL) Index
Functional Status will be assessed with the Barthel Activities of Daily Living (ADL) Index
Measured: Up to 3 months
Instrumented Activities of Daily Living (IADL)
Functional Status will be assessed with the Instrumented Activities of Daily Living (IADL) scores
Measured: Up to 3 months
Frailty
Frailty will be measured by modified Fried's criteria (Physical Frailty Phenotype)
Measured: Up to 3 months
Generalized anxiety
Measured: Up to 3 months
Depression
Depression will be measured with the Patient Health Questionnaire 9-Item Scale (PHQ-9).
Measured: Up to 3 months
Quality of life
Quality of life will be measured with a standardized instrument for use as a measure of health outcome EQ-5D
Measured: Up to 3 months
Routine laboratory
No additional blood samples will be taken in the pilot study
Measured: Up to hospital discharge, an expected average of 7 days
Organ dysfunctions
Organ dysfunctions are evaluated according to the Clavien-Dindo classification of surgical complications
Measured: Up to hospital discharge, an expected average of 7 days
Mortality
Mortality is evaluated in the pilot study
Measured: Up to three months
Postoperative pain
Postoperative pain will be measured with the Numeric Rating Scale (NRS-V) and validated scores
Measured: Up to 3 months
Mild cognitive impairment
Mild cognitive impairment will be measured by impaired performance in neuropsychological testing (neurocognitive test battery), level of functionality (ADL, IADL) and self report on cognitive impairment (Metamemory and FEDA questionnaire) and related to performance in the MOCA cognitive screening tool.
Measured: Up to 3 months
Timed up and go test
Measured: Up to 3 months
Continence
Measured by Deutscher Beckenboden-Fragebogen
Measured: Up to 3 months
Self report on cognitive deficits
Fragebogen erlebter Defizite der Aufmerksamkeit (FEDA)
Measured: Up to 3 months
Metamemory
Multifactorial Memory Questionnaire
Measured: Up to 3 months
Fatigue
2 questions
Measured: Up to 3 months
Assessment on cognitive deficits by Proxy (IQCODE)
Informant Questionnaire on Cognitive Decline in the Elderly
Measured: Up to 3 months
BIA (Bio-Impedanz-Analysis)
Measured: Up to 3 months
MNA Mini nutritional assessment-MNA short form)
Measured: Up to 3 months
Risk factors of dementia
Risk factors of dementia are analysed by blood levels of APOE-4, BDNF, Kynurenine, Zonulin, Endocan and Tryptophan
Measured: Up to 3 months
Pro- und anti-inflammatory cytokines
Measured: Up to 3 months
micro-RNA
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start25 Jul 2017
- Primary completion7 Sep 2018
- Study completion28 Sep 2018
Why it stopped: Lack of recruitment
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 Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747784
- Sponsor's protocol ID
- REACT
- Status last verified
- Nov 2020
- First submitted
- 30 Mar 2016
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rasmussen LS, Larsen K, Houx P, Skovgaard LT, Hanning CD, Moller JT; ISPOCD group. The International Study of Postoperative Cognitive Dysfunction. The assessment of postoperative cognitive function. Acta Anaesthesiol Scand. 2001 Mar;45(3):275-89. doi: 10.1034/j.1399-6576.2001.045003275.x.
PubMed 11207462
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation to Assess Cognitive Training for the Prevention of Post-operative Cognitive Decline (REACT) - a Pilot Study
- ClinicalTrials.gov ID
- NCT02747784
- Acronym / sponsor ID
- REACT
- Conditions
- Cognitive Dysfunction
- Keywords
- cognitive dysfunction, cognitive training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 7 Sep 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 22 Apr 2016 (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 open, monocentric randomized, parallel-group, controlled trial is to compare two different computer-based cognitive training programs regarding the efficacy to prevent the 3-months incidence of postoperative cognitive dysfunction in female patients after elective urogynecological or breast cancer surgery.
Detailed description
The REACT trial has been designed as a feasibility study to investigate the impact of pre-, peri-, and postoperative computerized cognitive trainings on the incidence of postoperative cognitive dysfunction. Two different study groups (training programs) will be compared. Each group consists of two training modules of the validated computer based training program of cognitive functioning called RehaCom®. The experimental group consists of the modules 'Topological Memory (MEMO)' and 'Divided Attention 2 (GEA2)'. The active comparator group consists of the modules 'Topological Memory (MEMO)' and 'Working memory (WOME)'. 48 surgical patients undergoing elective urogynecological or breast cancer surgery will preoperatively be randomly assigned to one of two study groups. Before starting the training, patients will complete a neuropsychological test battery comprising the cognitive tests to measure POCD. The tests will be assessed at preoperative baseline visit and at 3-months follow-up. In order to correct change in cognitive performance for practice effects, a group of 24 female surgical control subjects will also prospectively be tested with the cognitive test battery at baseline and 3-months follow-up. The control subjects will be matched to the 2 study groups regarding health status, surgery and age, but will neither undergo the computerized cognitive training program RehaCom®. Further, 24 female control subjects are included from the POCD-Register (EA1/104/16) and will be matched to the 2 study groups as well.
After baseline assessment, the study group patients will be taught to use the training program RehaCom®, and training should start preoperatively as early as possible. The patients are recommended to perform the training daily during inpatient hospital stay, and at least three times a week for 30 to 60 minutes until month 3.
The neuropsychological assessment will be performed at preoperative baseline and at three-months follow-up. Postoperative cognitive dysfunction (POCD) will be classified using the dichotomous approach established by Rasmussen et al in the International Study on postoperative cognitive deficits (ISPOCD) (Rasmussen et al. The assessment of postoperative cognitive function. Acta Anaesthesiol Scand. 2001 Mar;45(3):275-89.) This calculation method defines POCD as a reliable change in pre- and postoperative cognitive performance (difference scores) of each individual in the surgical patients cohort as compared to the changes in a non-surgical control group (reliable change index in either a composite score including cognitive test parameters from all tests in the cognitive test battery or in at least two of the chosen cognitive test parameters).
Secondary outcome measures of this trial comprise structural and functional MRI measures, Electroencephalogram simultaneous with fMRI, intraoperative cerebral oximetry and neuromonitoring, delirium, pain, sleep quality, postoperative complications, frailty, psychological distress, quality of life, training performance and evaluation of the training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group experimental | Experimental | Behavioral: Cognitive training program RehaCom®24 female patients aged 18 years or older undergoing urogynecological or breast cancer surgery; the patients are recommended to perform the RehaCom® training modules 'Topological Memory (MEMO)' and 'Divided Attention 2 (GEA2)' daily during inpatient hospital stay, and at least three times a week for 30 to 60 minutes until month 3. |
| Study group active comparator | Active comparator | Behavioral: Cognitive training program RehaCom®24 female patients aged 18 years or older undergoing urogynecological or breast cancer surgery; the patients are recommended to perform the RehaCom® training modules 'Topological Memory (MEMO)' and 'Working memory (WOME)' daily during inpatient hospital stay, and at least three times a week for 30 to 60 minutes until month 3. |
| Control group | No intervention | –48 female control subjects aged 18 years or older (24 without surgery, 24 with urogynecological or breast cancer surgery) with a similar health status and age as the study group patients (similar distribution in the American Society of Anaesthesiologists physical status classification and relevant co-morbidities, e.g. diabetes, coronary artery disease, hypertension and hyperlipidemia). The patients are analyzed to correct for learning effects of the cognitive assessment testings in the study groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pilot study: Female patients undergoing urogynecological or breast cancer surgery, screened at the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany
- Age 18 years or older
- Montreal Cognitive Assessment Score (MOCA) > 25
- Patient has access to Personal computer or Laptop with system software Windows XP Service Pack 3 (or newer); tablets or smart phones cannot by used.
- Written informed consent to participate after having been properly instructed
Key exclusion criteria (16 listed)
- Apparent dementia
- Lacking willingness to take part in the study, or to have relevant study data collected, saved and analyzed for the purpose of the study
- Lacking willingness to be contacted by telephone or mail.
- Accommodation in an institution due to an official or judicial order
- Insufficient knowledge of German language
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 |
|---|---|---|
| Cognitive training program RehaCom®Cognitive training program RehaCom® | Behavioural | Study group active comparator, Study group experimental |
Primary outcome
Incidence of postoperative cognitive dysfunction (POCD)
Time frame: Up to 3 months
Cognitive functioning will be measured with a battery of computerized neuropsychological tests, non-computerized and computer-based tests from the Cambridge Neuropsychological Test Automated Battery [CANTAB®]
38 secondary outcomes
Divided attention
Time frame: Up to 3 months
Incidence of postoperative delirium
Time frame: Up to 7 days
Intraoperative depth of sedation
Time frame: At time of surgery
Depth of sedation on the Intensive Care Unit
Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Intraoperative cerebral oximetry
Time frame: At time of surgery
Quality of sleep
Time frame: Up to 3 months
Anxiety
Time frame: Up to hospital discharge, an expected average of 7 days
Intensive care unit length of stay
Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Hospital length of stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Evaluation of the cognitive training program RehaCom® by patient
Time frame: Up to 3 months
Performance of cognitive training units of the program RehaCom®
Time frame: Up to 3 months
Duration of the cognitive training of the program RehaCom®
Time frame: Up to 3 months
Frequency of the cognitive training of the program RehaCom®
Time frame: Up to 3 months
MRI assessment
Time frame: Up to 3 months
MRI assessment
Time frame: Up to 3 months
MRI assessment
Time frame: Up to 3 months
Barthel Activities of Daily Living (ADL) Index
Time frame: Up to 3 months
Instrumented Activities of Daily Living (IADL)
Time frame: Up to 3 months
Frailty
Time frame: Up to 3 months
Generalized anxiety
Time frame: Up to 3 months
Depression
Time frame: Up to 3 months
Quality of life
Time frame: Up to 3 months
Routine laboratory
Time frame: Up to hospital discharge, an expected average of 7 days
Organ dysfunctions
Time frame: Up to hospital discharge, an expected average of 7 days
Mortality
Time frame: Up to three months
Postoperative pain
Time frame: Up to 3 months
Mild cognitive impairment
Time frame: Up to 3 months
Timed up and go test
Time frame: Up to 3 months
Continence
Time frame: Up to 3 months
Self report on cognitive deficits
Time frame: Up to 3 months
Metamemory
Time frame: Up to 3 months
Fatigue
Time frame: Up to 3 months
Assessment on cognitive deficits by Proxy (IQCODE)
Time frame: Up to 3 months
BIA (Bio-Impedanz-Analysis)
Time frame: Up to 3 months
MNA Mini nutritional assessment-MNA short form)
Time frame: Up to 3 months
Risk factors of dementia
Time frame: Up to 3 months
Pro- und anti-inflammatory cytokines
Time frame: Up to 3 months
micro-RNA
Time frame: Up to 3 months
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Background: PubMed 11207462Rasmussen LS, Larsen K, Houx P, Skovgaard LT, Hanning CD, Moller JT; ISPOCD group. The International Study of Postoperative Cognitive Dysfunction. The assessment of postoperative cognitive function. Acta Anaesthesiol Scand. 2001 Mar;45(3):275-89. doi: 10.1034/j.1399-6576.2001.045003275.x.
- Individual participant dataSharing planned: No
Related trials for Cognitive Dysfunction
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
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.
Claudia Spies, MD, Prof. study director
Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training program RehaCom® in people with Cognitive Dysfunction, run by Charite University, Berlin, Germany at 1 site in Germany.
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 8 inclusion and 16 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: stopped early, as of the sponsor's last update on 25 Nov 2020. 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 Germany. 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 was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
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?
Incidence of postoperative cognitive dysfunction (POCD) (time frame: Up to 3 months). 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 NCT02747784, 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 25 Nov 2020.