Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT06312969
Eligibility Criteria:
Inclusion Criteria:
* Patients between 8 and 17 years of age at the time of recruitment.
* Have completed treatment between 1 and 6 years prior to recruitment.
* Have had one of the following diagnoses:
* Patients with CNS disease (posterior fossa tumors and supratentorial gliomas smaller than 1 cm affecting associative areas).
* Patients with hematologic malignancies (leukemia or lymphoma).
* Patients with solid tumors.
* Patients with non-malignant hematological diseases and indication for allogeneic hematopoietic progenitor transplantation.
* Having received at least one of the following treatments:
* Central nervous system surgery.
* Central nervous system radiotherapy.
* Intrathecal/intraventricular chemotherapy.
* Neurotoxic systemic chemotherapy.
* Hematopoietic stem cell transplantation.
* Informed consent signed by parent/guardian.
Exclusion Criteria:
* Active oncologic disease or relapse of active oncologic disease.
* Prior neurological or psychiatric pathology that may preclude trial or treatment evaluations:
* Psychological or neurocognitive illness or sequelae that preclude neuropsychological assessment or are expected to significantly artifact MRI results (examples: significant decrease in visual acuity, CNS surgical scar that artifacts imaging results, severe cognitive delay that precludes testing, etc.).
* Psychological or neurocognitive illnesses or sequelae that prevent or contraindicate the use of video games (epilepsy that prevents the use of screens, significant decrease in visual acuity, etc.).
* Mild or self-limiting neurological or psychiatric pathology that does not interfere with trial diagnosis and treatment (headache, epilepsy in remission with effective treatment, mild cognitive delay, etc.) will be allowed.
* Current or recent (less than 1 year) use of other cognitive stimulation or brain training that may interfere with study results.
* Refusal to abstain from the use of the study treatment games in case of being assigned to group B (control group).
* Medical treatment that may significantly interfere with neuropsychological, imaging or biomarker assessments.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT06312969
Study Brief:
Protocol Section:
NCT06312969