Cognitive Rehabilitation for Brain Tumor

Overseen By Jennie Taylor, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Anti-epileptics

Disqualifiers: Glioblastoma, Meningioma, Suicidal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 12 weeks

97 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether cognitive rehabilitation can help people with brain tumors improve their attention and memory. The treatments being tested include in-person cognitive rehabilitation, a telehealth cognitive rehabilitation option, and the use of the ReMind iPad app. These methods have proven successful in individuals with brain injuries and strokes, but their effectiveness in brain tumor patients remains unknown. Candidates may be suitable if they have a low-grade brain tumor, have undergone surgery, and are experiencing memory or attention issues. Participants must be stable and have internet access. As an unphased trial, this study offers the opportunity to contribute to groundbreaking research that could enhance cognitive rehabilitation options for brain tumor patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must have adequate seizure control and be on a stable or decreasing dose of anti-epileptics.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that cognitive rehabilitation is safe and beneficial for individuals with brain tumors. For in-person sessions, research indicates improvements in areas like memory and attention for cancer patients. These treatments are generally well-tolerated, with no major safety concerns reported.

Telehealth cognitive rehabilitation, similar to therapy sessions over video calls, is also safe. Trials found it practical and effective, enhancing memory and other cognitive functions in brain tumor patients without introducing significant risks.

The ReMind iPad app, used for cognitive rehabilitation, is supported by evidence demonstrating its safety and effectiveness. Most users found the app easy to use, and it improved their cognitive functions without causing harm.

Additionally, using healthy SMS texting, which involves sending educational and supportive text messages, is generally safe. Studies suggest that regular cell phone use does not increase the risk of brain tumors, supporting the safety of this approach.

Overall, these cognitive rehabilitation methods are well-tolerated and safe for individuals with brain tumors, according to existing research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these cognitive rehabilitation treatments for brain tumors because they offer innovative ways to enhance cognitive recovery. Unlike traditional methods, the in-person and telehealth cognitive rehab use evidence-based strategies recommended by leading experts in cognitive rehabilitation to tailor treatment to individual needs. The telehealth approach, in particular, offers the flexibility of remote access, making it a convenient option for patients who cannot travel for in-person sessions. Additionally, the ReMind iPad app introduces a novel, game-like training that harnesses brain plasticity to improve attention and memory—an exciting development in cognitive therapy. These unique features have the potential to significantly improve cognitive outcomes for patients with brain tumors.

What evidence suggests that this trial's cognitive rehabilitation treatments could be effective for brain tumor patients?

Studies have shown that cognitive rehabilitation can improve thinking and memory skills in people with brain tumors. This trial offers participants various forms of cognitive rehabilitation. Research indicates that in-person cognitive rehabilitation, one option in this trial, effectively boosts or maintains these abilities. Similarly, telehealth for cognitive rehabilitation, another option, has improved memory in brain tumor survivors. The ReMind iPad app, also under study, has shown promise in enhancing thinking skills and quality of life, with many participants finding it helpful. Although evidence for the healthy SMS texting intervention is less clear, early use in other conditions like depression has shown potential. Overall, these treatments aim to address thinking and memory problems caused by brain tumors or their treatments. ^{5 6 7 8 9}

Who Is on the Research Team?

Jennie W Taylor, MD, MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Adults over 18 with low-grade brain tumors who speak English, have internet and text-enabled phones, are treated at UCSF, and have stable seizures. They must be post-surgery but not on recent tumor treatment, complain of cognitive issues, perform poorly on cognitive tests, and expect to live more than 12 weeks.

Inclusion Criteria

I am having or had brain surgery at UCSF for a low-grade tumor within the last 3 months.

You are expected to live for more than 12 weeks.

I feel like my memory or thinking skills have gotten worse.

Exclusion Criteria

I have been diagnosed with glioblastoma, meningioma, or infra-tentorial disease.

Are not able to comply with study and/or follow-up procedures

You are currently experiencing severe mental health issues such as suicidal thoughts, active psychosis, or being unable to take care of yourself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive rehabilitation therapy through various methods including in-person, telehealth, ReMind app, and SMS texting over 12 weeks

12 weeks

Every 2 weeks for in-person and telehealth; weekly for ReMind app; daily SMS

Follow-up

Participants are monitored for cognitive changes and quality of life at 3 and 9 months post-intervention

9 months

Assessments at 3 and 9 months

Longitudinal Follow-up

Participants undergo cognitive and quality of life assessments every 6 months for 3 years after surgery

36 months

Every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Healthy SMS texting
• In-person cognitive rehabilitation
• ReMind iPad app
• Telehealth cognitive rehabilitation

Trial Overview The trial is testing if SMS texting reminders, a ReMind iPad app or telehealth sessions can help improve attention and memory in adults who've had surgery for low-grade brain tumors. It compares these methods to see which might aid recovery best.

How Is the Trial Designed?

Group I: Arm 1 Cohort 3: Interventional arm/Healthy SMS texting (CLOSED) Experimental Treatment 1 Intervention

The mobile phone texting intervention was developed with collaborators at Zuckerberg San Francisco General Hospital and is currently being studied in individuals with depression and traumatic brain injury. Participants receive a daily message sent at a random time (within their chosen timeframe(s); e.g. 9am-9pm). Messages will focus on patient-based education-focused health-related quality of life and cognitive education such as internal and external cognitive compensatory strategy training, fatigue management, and coping skills. n = 20 patients

Group II: Arm 1 Cohort 2: Interventional arm/ReMind iPad app (CLOSED) Experimental Treatment 1 Intervention

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

Group III: Arm 1 Cohort 1A: Telehealth Cognitive Rehabilitation Experimental Treatment 1 Intervention

The telehealth cognitive rehabilitation will take place over secure UCSF Zoom. It 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. During treatment implementation, patients acquire, apply, and adapt evidenced based strategies based on neuropsychological testing and conjointly developed treatment planning goals. N=20

Group IV: Arm 1 Cohort 1: Interventional arm/In-person rehab (CLOSED) Experimental Treatment 1 Intervention

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

Group V: Arm 2 Cohort 4: Longitudinal arm/Upfront radiation Active Control 1 Intervention

Patients will undergo longitudinal global cognitive and HRQOL assessments at baseline prior to surgery, after surgery, 3 months after surgery and every 6 months for 3 years. Clinical data will be collected at the time of each assessment. This will include changes in serial imaging e.g. in T2 tumor volume, DTI scalar quantification, resting-state fMRI connectivity n = 50 patients

Group VI: Arm 1 Cohort 5: Longitudinal arm/No upfront radiation Active Control 1 Intervention

Patients will undergo longitudinal global cognitive and HRQOL assessments at baseline prior to surgery, after surgery, 3 months after surgery and every 6 months for 3 years. Clinical data will be collected at the time of each assessment. This will include changes in serial imaging e.g. in T2 tumor volume, DTI scalar quantification, resting-state fMRI connectivity n = 50 patients

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Tilburg University

Collaborator

Trials

43

Recruited

21,300+

University of California, Berkeley

Collaborator

Trials

193

Recruited

716,000+

Published Research Related to This Trial

A study involving 74 adults with cancer-related cognitive impairment showed that the Cognitive Retraining and Functional Treatment (CRAFT) program, which combines cognitive training and occupation-based treatment, significantly improved participation in daily life and cognitive performance compared to standard treatment.

CRAFT not only enhanced cognitive outcomes but also led to greater treatment satisfaction and maintained these benefits at a 3-month follow-up, indicating its potential as an effective intervention for improving quality of life in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Retraining and Functional Treatment (CRAFT) for adults with cancer related cognitive impairment: a preliminary efficacy study. Maeir, T., Makranz, C., Peretz, T., et al.[2023]

The ReMind app, an iPad-based cognitive rehabilitation program, was found to be feasible for patients with primary brain tumors, with 85% of participants rating it as 'good' or 'excellent' and expressing willingness to recommend it to others.

In a pilot study involving 15 patients, participants completed a significant portion of the training (71% strategy training and 76% retraining), indicating good adherence, although some found the exercises too easy, leading to plans for more challenging content in future evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of the evidence-based cognitive telerehabilitation program Remind for patients with primary brain tumors. van der Linden, SD., Sitskoorn, MM., Rutten, GM., et al.[2019]

A 4-week conventional rehabilitation therapy significantly improved functional outcomes in both brain tumor patients and subacute stroke patients, indicating its effectiveness in enhancing daily activity functions.

In brain tumor patients, initial cognitive and motor assessments were strong predictors of their daily activity function, suggesting that targeted cognitive training could further enhance rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Improvement After 4-Week Rehabilitation Therapy and Effects of Attention Deficit in Brain Tumor Patients: Comparison With Subacute Stroke Patients. Han, EY., Chun, MH., Kim, BR., et al.[2020]

A tablet-based cognitive rehabilitation program called ReMind was evaluated in 62 brain tumor patients, but it did not show significant improvements in cognitive performance or psychological outcomes compared to a control group.

Despite the lack of statistical significance in cognitive outcomes, participants reported high satisfaction with the program, indicating that while the intervention may not have been effective in this study, it could still be beneficial if tailored to better meet patients' needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

eHealth cognitive rehabilitation for brain tumor patients: results of a randomized controlled trial. van der Linden, SD., Rutten, GM., Dirven, L., et al.[2022]

Citations

1. mdpi.com mdpi.com/1660-4601/17/21/8079

Cellular Phone Use and Risk of Tumors This comprehensive meta-analysis of case-control studies found evidence that linked cellular phone use to increased tumor risk.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10946492/

Evaluation of the telehealth making sense of brain tumor ... Hence, the current trial demonstrated that an extended brain‐tumor specific intervention yielded better clinical outcomes for people with PBT than brief ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1878875025002633

Utilising Natural Language Processing to Identify Brain ... This study demonstrated the effectiveness of NLP in screening clinical notes for the identification of brain tumor diagnoses. Additionally, the study utilized ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8484142/

eHealth cognitive rehabilitation for brain tumor patients The few studies that have been conducted on cognitive rehabilitation in adults with brain tumors demonstrated positive effects on cognitive ...

5. ehjournal.biomedcentral.com ehjournal.biomedcentral.com/articles/10.1186/s12940-024-01117-8

meta-analyses using various proxies for RF-EMR exposure ... The authors conducted meta-analyses regarding the association between cellular and mobile phone use and brain tumor development.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9086806/

Cellular Telephone Use and the Risk of Brain Tumors Our findings support the accumulating evidence that cellular telephone use under usual conditions does not increase brain tumor incidence.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0160412024001387

Mobile phone use and brain tumour risk – COSMOS, a ... Our findings suggest that the cumulative amount of mobile phone use is not associated with the risk of developing glioma, meningioma, or acoustic neuroma.

8. cancer.gov cancer.gov/about-cancer/causes-prevention/risk/radiation/cell-phones-fact-sheet

Cell Phones and Cancer Risk Fact Sheet - NCI The evidence to date suggests that cell phone use does not cause brain or other kinds of cancer in humans.

9. uhhospitals.org uhhospitals.org/blog/articles/2025/01/can-cell-phones-cause-brain-cancer

Can Cell Phones Cause Brain Cancer? The World Health Organization (WHO) recently published a large-scale research review that found no connection between cell phone use and an increased risk of ...