NCT02747784 · TERMINATED
Evaluation to Assess Cognitive Training for the Prevention of Post-operative Cognitive Decline
This trial tested whether a computer-based cognitive training program called RehaCom could reduce the risk of post-operative cognitive decline in women having urogynecological or breast cancer surgery. Researchers compared it against another computer training program and tracked thinking and memory changes over three months. This is a Phase NA trial, meaning it is a practical pilot study rather than a standard drug-efficacy phase — early-stage and exploratory.
Eligibility criteria
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2020-11-25