Evaluation to Assess Cognitive Training for the Prevention of Post-operative Cognitive Decline
NCT ID: NCT02747784
Last Updated: 2020-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
19 participants
INTERVENTIONAL
2017-07-25
2018-09-28
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Study group 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.
Cognitive training program RehaCom®
Cognitive training program RehaCom®
Study group 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.
Cognitive training program RehaCom®
Cognitive training program RehaCom®
Control group
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.
No interventions assigned to this group
Interventions
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Cognitive training program RehaCom®
Cognitive training program RehaCom®
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Claudia Spies
Head of the Department of Anesthesiology and Intensive Care Medicine, Campus Virchow - Klinikum (CVK)/Campus Charité Mitte (CCM), Charité - University Medicine Berlin
Principal Investigators
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Claudia Spies, MD, Prof.
Role: STUDY_DIRECTOR
Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin
Locations
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Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin
Berlin, , Germany
Countries
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References
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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.
Other Identifiers
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REACT
Identifier Type: -
Identifier Source: org_study_id