Clinical trial · Interventional
Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
NCT03948490CI-TRIAL-00117942recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low-grade Glioma | Low Grade Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Healthy SMS texting | Device | — | UNRESOLVED |
| In-person cognitive rehabilitation | Behavioral | — | UNRESOLVED |
| ReMind iPad app | Device | — | UNRESOLVED |
| Telehealth cognitive rehabilitation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- OTHER
- label
- Arm 1 Cohort 1: Interventional arm/In-person rehab (CLOSED)
- description
- The in-person cognitive rehabilitation will focus on the application of evidenced based strategies recommended as practice guidelines by the American Congress of Rehabilitation Medicine Cognitive Rehabilitation Task Force (ACRM-CR). The treatment occurs in two stages 1) comprehensive neuropsychological assessment and rehabilitation planning and 2) implementation of treatment planning. n = 20 patients
- interventionNames
- Behavioral: In-person cognitive rehabilitation
- type
- EXPERIMENTAL
- label
- Arm 1 Cohort 2: Interventional arm/ReMind iPad app (CLOSED)
- description
- The ReMind iPad-based cognitive rehabilitation was developed with collaborators at Tilburg University, The Netherlands, and is an evidence-based program to improve attention and memory through (1) cognitive training and (2) teaching compensatory skills in patients with brain tumors. Brain plasticity-based computerized cognitive training is a newly developing field of therapeutics for neurological and psychiatric disorders that uses frequent game-like training sessions to drive improvements in cognitive functions. n = 20 patients
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.