BridgeMD
New treatment option for Low-grade Glioma
Official title Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
ClinicalTrials.gov ID: NCT03948490
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Arm 1:
- Histologically confirmed low grade supratentorial primary brain tumor
- \>= 18 years old
- Life expectancy \> 12 weeks
- Karnofsky performance status (KPS) \>= 70
You likely can't join if
- 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...
See the full eligibility criteria
- Arm 1:
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.