Neuropsychological Test Clinical Trial
— MentalPlus®Official title:
Cognitive Function Evaluation and Rehabilitation by a Digital Game: MentalPlus®
| Verified date | March 2024 |
| Source | University of Sao Paulo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Cognitive dysfunction is a frequent adverse event in the postoperative period, especially in elderly patients. The tests commonly used for the detection of postoperative cognitive dysfunction (POCD) are time-consuming, which limits routine use. Consequently, there is a limitation to adopting measures to increase preoperative cognitive reserve and rehabilitation of POCD. That situation incentivizes searching for alternative diagnosis methods to overcome that limitation. Digital games have potential neuromodulator effects and have been used as an alternative to psychotherapeutic treatment. However, the tests used to detect postoperative cognitive dysfunction (POCD) are time-consuming, making it difficult to implement routine screening measures. This presents a challenge for increasing preoperative cognitive reserve and rehabilitating POCD. Researchers are exploring alternative diagnostic methods, such as digital games, to address this challenge. Digital games have potential neuromodulator effects and are an alternative to psychotherapeutic treatments and cognitive rehabilitation. This study aims to validate MentalPlus®, a digital game, as a tool for cognitive assessment, POCD evaluation, and POCD rehabilitation-habilitation of mental skills. It is hypothesized that a digital game could replace the usual neuropsychological tests for detecting POCD.
| Status | Completed |
| Enrollment | 163 |
| Est. completion date | November 29, 2023 |
| Est. primary completion date | November 29, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - Individuals who accept the invitation will be first submitted to the TICS Instrument (Telephone Interview Cognitive Status), which aims to verify the global cognitive status of the subject evaluated. Will be included subjects with TICS score >25. Exclusion Criteria: - Patients who do not meet the TICS inclusion criteria will be excluded at this stage and informed that they did not fulfill all the requirements for the study. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Livia Stocco Sanches Valentin | São Paulo | SP |
| Lead Sponsor | Collaborator |
|---|---|
| University of Sao Paulo | California Institute of Technology, Harvard Medical School (HMS and HSDM), Karolinska Institutet, Keio University, Max Planck Institute for Human Development, The Cleveland Clinic, UMC Utrecht, University of California, Los Angeles, University of Copenhagen |
Brazil,
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* Note: There are 24 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Validation of MentalPlus® digital game as a neuropsychological test for assess cognitive functions: executive, attention, memory and language. | Cognitive evaluation of 60 patients in the pre and postoperative period using the MentalPlus scale for the evaluation of postoperative cognitive dysfunction. | 1 year |