Evaluation to Assess Cognitive Training for the Prevention of Post-operative Cognitive Decline

Charite University, Berlin, Germany19 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Cognitive Dysfunction

Interventions

Cognitive training program RehaCom®BEHAVIORAL

Cognitive training program RehaCom®

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Study groups Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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 Inclusion Criteria: 24 female surgical control subjects from the POCD Register (EA1/104/169) and 24 female non-surgical control subjects

Locations (1)

Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin

Berlin, Germany

Outcomes

Primary Outcomes

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 \[CANTAB®\]

Time frame: Up to 3 months

Secondary Outcomes

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.

Time frame: 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

Time frame: 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®.

Time frame: 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)

Time frame: 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.

Time frame: At time of surgery

Data from ClinicalTrials.gov

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