← Back to Search

Cognitive Rehabilitation for Brain Tumor

N/A

Waitlist Available

Led By Jennie Taylor, MD, MPH

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a presumed low grade supratentorial primary brain tumor and either be undergoing definitive surgery at UCSF or have had surgical resection at UCSF within the last 3 months.

Histologically confirmed low grade supratentorial primary brain tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial will test the feasibility and efficacy of cognitive rehabilitation in brain tumor patients.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since the interventions involve non-invasive techniques like texting and cognitive exercises through an app or telehealth sessions rather than medication or surgery, significant side effects are not expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

My brain tumor is confirmed to be low grade and located above the tentorium.

Select...

I am 18 years old or older.

Select...

I am able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants who show a decline of >= 1.5 SD from baseline on the Wechsler Adult Intelligence Scale IV (WAIS-IV) Working Memory Score or Hopkins Verbal Learning Test (HVLT) (Arm 2)

Percentage of subjects who complete all of the intervention exercises for each cohort (Arm 1)

Secondary outcome measures

Assess relation ships between cognitive changes and clinical factors (Arm 2)

Assess relationships between cognitive changes and serial magnetic resonance (MR) imaging (Arm 2)

Correlation between isodose lines and cognitive changes (Arm 2)

+3 more

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1 Cohort 3: Interventional arm/Healthy SMS texting (CLOSED)Experimental Treatment1 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 Treatment1 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 RehabilitationExperimental Treatment1 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 Treatment1 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 radiationActive Control1 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 radiationActive Control1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,500 Previous Clinical Trials

15,236,404 Total Patients Enrolled

Tilburg UniversityOTHER

37 Previous Clinical Trials

20,235 Total Patients Enrolled

University of California, BerkeleyOTHER

180 Previous Clinical Trials

721,119 Total Patients Enrolled

Media Library

Low Grade Glioma Research Study Groups: Arm 1 Cohort 3: Interventional arm/Healthy SMS texting (CLOSED), Arm 2 Cohort 4: Longitudinal arm/Upfront radiation, Arm 1 Cohort 5: Longitudinal arm/No upfront radiation, Arm 1 Cohort 1: Interventional arm/In-person rehab (CLOSED), Arm 1 Cohort 2: Interventional arm/ReMind iPad app (CLOSED), Arm 1 Cohort 1A: Telehealth Cognitive Rehabilitation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What results are researchers hoping to achieve from this investigation?

"This clinical trial is designed to assess the efficacy of intervention exercises over a three-year period. Primary outcome measures include participants completing the interventions for each cohort and secondary outcomes involve improvement in patient-reported quality of life scores as well as cognitive domain changes from baseline."

Answered by AI

Is enrollment for this trial still available?

"Affirmative, the online data reveals that this scientific experiment is recruiting participants. It was initially launched on June 7th 2019 and most recently amended on November 16th 2022. 180 subjects must be recruited from a single clinical site."

Answered by AI

What is the current enrollment rate for this clinical experiment?

"Affirmative. The details on clinicaltrials.gov demonstrate that this medical experiment, which was initially posted on June 7th 2019, is presently seeking participants. Approximately 180 individuals need to be recruited from 1 research facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas

2019. "Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03948490.