Postoperative Cognitive Impairment after Intracranial Tumor Surgery
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed intracranial tumor, with cognitive dysfunction occurring after craniotomy. 2. Age at enrollment >=18 and =16 weeks. 4. Karnofsky Performance Status (KPS) score >=70. 5. Able to use a smartphone with internet access, expected to independently complete the game-based training, and likely able to pass the first level of the game. 6. Baseline assessment indicates cognitive impairment: postoperative patients with a Montreal Cognitive Assessment (MoCA, Beijing version) score =4 days per week and >=4 hours per day, and is willing to accompany the subject to study visits. 8. The subject and/or their legal guardian can understand the purpose of the study, demonstrate adequate compliance with the study protocol, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Currently taking psychotropic medications or having other conditions that are expected to prevent completion of device operation. 2. The investigator judges the subject’s condition to be unstable. 3. Patients with blindness or deafness, or those with Alzheimer’s disease. 4. Concurrent participation in another clinical study, unless it is an observational, non-interventional study. 5. Known history of psychiatric disorders, substance abuse, alcoholism, or drug use. 6. Pregnant or breastfeeding women. 7. Any other conditions in which the investigator, in consideration of the subject’s best interests, determines that the subject should not participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Loewenstein Occupational Therapy Cognitive Assessment (LOTCA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Montreal Cognitive Assessment (MoCA), Beijing version;Beijing version, and the European Organisation for Research and Treatment of Cancer Quality of Life; | — |
Countries
China
Contacts
The First Affiliated Hospital,Sun Yat-sen University