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:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT05984667
Eligibility Criteria:
Inclusion Criteria:
1. Confirmed primary brain tumor diagnosis by histology or neuro-oncologist review of imaging
2. At least one domain of neurocognitive function \>1.5 SD below the average or the individual's estimated premorbid functioning, using the expanded ICCTF clinical trials battery and Test of Premorbid Functioning for comparison
3. \>1 month post brain surgery and/or radiation therapy, if applicable
4. Estimated premorbid intelligence \>75.
5. Patients must be age 18+ and primarily English speaking
Exclusion Criteria:
1. Presence of major neurocognitive impairment that would prevent participation in the intervention, and/or severe aphasia, and/or inability to understand and provide informed consent
2. Inability to attend weekly telehealth appointments; based on EAB results
3. Clinically significant insomnia symptoms
4. \< 1 month post brain surgery and/or radiation therapy
5. Unstable internet connection or an inability to work teleconferencing software. Participants will be supplied an iPad if they do not have an adequate device.
6. To participate in the fMRI portion of this study participants cannot have any metal in their bodies. For the fMRI subset, participants cannot have metal in their body as the MRI scan could cause them harm and if female of childbearing years, they cannot be pregnant as the MRI scan may pose risk to the unborn fetus.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05984667
Study Brief:
Protocol Section:
NCT05984667