NCT03948490 Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
| NCT ID | NCT03948490 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Low-grade Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 117 participants |
| Start Date | 2019-06-07 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 117 participants in total. It began in 2019-06-07 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients with glial brain tumors have increasingly improved outcomes, with median survival of 5-15 years. However, the treatments, including surgery, radiation, and chemotherapy, often lead to impaired attention, working memory, and other cognitive functions. These cognitive deficits frequently have significant impact on patient quality of life. Although currently, there is no established standard of care to treat cognitive deficits in brain tumor patients, standard cognitive rehabilitative treatments have been developed for those with traumatic brain injury and stroke. However, the feasibility and efficacy of these cognitive treatments in individuals with brain tumors remains unclear.
Eligibility Criteria
Arm 1: Inclusion Criteria: * Histologically confirmed low grade supratentorial primary brain tumor * \>= 18 years old * Life expectancy \> 12 weeks * Karnofsky performance status (KPS) \>= 70 * Must speak and be able to read English fluently * Must have access to the internet * Must have text enabled cellphone * Must be receiving MRI scans at University of California, San Francisco (UCSF) * Must be clinically stable and off treatment (e.g. radiation or chemotherapy) for ≥ 3 months * Must be \>= 6 months from craniotomy * Must have subjective complaints of cognitive deficits * Must have adequate seizure control and be on a stable, or decreasing, dose of anti-epileptics * Must score \<= 1 SD below normal on ≥ 2 or more domains of baseline neuropsychological assessments Exclusion Criteria: * Diagnosis or evidence of any of the following: * • Glioblastoma * • Extra-axial disease (i.e. meningioma) * • Infra-tentorial disease * Are not able to comply with study and/or follow-up procedures * Are unable to complete or score \>= 3 cognitive tests at baseline, which is indicative that patients would be unable to complete the cognitive rehabilitation interventions * Are acutely suicidal, psychotic, and/or gravely disabled. * Patients who, based on the neuropsychologist's opinion, are unable to participate in cognitive testing and/or cognitive rehab secondary to significant neurologic deficit Arm 2: Inclusion Criteria: * Have a presumed lower grade IDH-mutated primary brain tumor and either be undergoing definitive surgery or have had surgical resection within the last 4 months. * Prior surgery is allowed if they have not received additional tumor directed treatment. * \>= 18 years old * Must speak and be able to read English fluently. * Plan to continue to care in neuro-oncology at UCSF * Must be receiving MRI scans. Exclusion Criteria: * Diagnosis or evidence of any of the following: * • Primary brain tumor classified as CNS WHO Grade 4 * • Extra-axial disease (i.e. meningioma) * Are not able to comply with study and/or follow-up procedures * Have acute psychiatric issues (suicidality, active psychosis, gravely disabled)
Contact & Investigator
Jennie Taylor, MD, MPH
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT03948490 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Low-grade Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03948490 currently recruiting?
Yes, NCT03948490 is actively recruiting participants. Contact the research team at jennie.taylor@ucsf.edu for enrollment information.
Where is the NCT03948490 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT03948490 clinical trial?
NCT03948490 is sponsored by University of California, San Francisco. The principal investigator is Jennie Taylor, MD, MPH at University of California, San Francisco. The trial plans to enroll 117 participants.