Cognitive Rehabilitation for Survivors of Childhood Medulloblastoma Using Real Time Hemodynamic Neurofeedback
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Enrollment Rate Among Approached Survivors (%)
研究概览
简要总结
This study will evaluate a new way to help childhood medulloblastoma survivors improve their thinking and memory skills. Many survivors experience long term challenges with attention and working memory because of the tumor and its treatments. The study uses real time neuroimaging technologies such as real time functional magnetic resonance imaging (rt-fMRI) and real time functional near infrared spectroscopy (rt-fNIRS) make it possible to monitor and display a participant's brain activity as it occurs. Neurofeedback uses this activity to provide individuals with immediate visual information about how specific brain regions are functioning, potentially enabling them to learn strategies to modulate or improve brain activity linked to thinking skills.
Participants are randomly assigned to one of two groups. One group receives feedback from a brain area involved in working memory, and the other receives feedback from a different brain region as a comparison. Over three visits, participants complete brain scans, neurofeedback sessions, and thinking and memory tests.
The main goal is to see if this type of brain training is practical, safe, and comfortable for survivors. The study also looks at whether the training may help improve brain activity and working memory performance.
Primary Objective(s):
• To evaluate the feasibility of real time Hemo-NFB neurofeedback training in medulloblastoma survivors.
Secondary Objective(s):
• To estimate the initial efficacy of Hemo-NFB neurofeedback to up-regulate the activity of the dorsolateral prefrontal cortex (DLPFC) and improve WM performance.
详细描述
Survivors of childhood medulloblastoma often have lasting problems with attention, working memory, and processing speed due to the tumor and its treatment (surgery, radiation, and chemotherapy). These changes commonly affect attention, working memory, and processing speed, which can interfere with school and daily activities
Because current treatment options for cognitive problems are limited, researchers are studying new methods to support survivors. This study evaluates real time neuroimaging technologies such as real time functional magnetic resonance imaging (rt-fMRI) and real time functional near infrared spectroscopy (rt-fNIRS) to monitor and display a participant's brain activity as it occurs. Neurofeedback uses this activity to provide individuals with immediate visual information about how specific brain regions are functioning, potentially enabling them to learn strategies to modulate or improve brain activity linked to thinking skills. By watching this activity, participants may learn to "train" specific brain regions to work more effectively.
Survivors aged 10-25 years who show signs of working memory difficulties will be invited to participate. They will be randomly assigned to receive neurofeedback from either the dorsolateral prefrontal cortex-a part of the brain important for working memory-or from the primary auditory cortex, which serves as a comparison condition. Both groups follow the same schedule and receive the same amount of training.
Participants visit the study team three times over a period of 10 days to 3 weeks. During these visits, they take part in thinking and memory tests, perform working memory tasks inside the MRI scanner, and complete several short neurofeedback sessions. The study team will assess for any side effects, such as nausea or dizziness, before and after each scan.
The study will assess early signs of benefit, such as whether neurofeedback helps participants increase activity in key brain areas and whether this relates to improvements in their thinking and memory test scores. The results will help guide a larger study in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
In this double-blinded, randomized study, participants will be stratified by age (10 - <17y and 18 -<25y) and within each stratum, subjects will be randomized 2:1 to receive intervention or control.
入排标准
- 年龄范围
- 10 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 10 and ≤ 25 years at the time of enrollment.
- •English as a primary language.
- •Current St. Jude participants who received treatment for medulloblastoma with upfront craniospinal radiotherapy (proton or photon), inclusive of SJMB12 participants and those treated as per SJMB12 at least 2 years from completion of treatment of their medulloblastoma.
- •Demonstrate working memory impairment based on age-appropriate questionnaire electronically administered pre-enrollment. Specifically, scores >57 on the Working Memory Index of the BRIEF (places the individual in the top 25% of people who have difficulty with working memory tasks).
排除标准
- •History of seizures, on or off antiepileptic drugs, in the past 3 months.
- •A premorbid history of significant neurological disease, including stroke or head injury with loss of consciousness.
- •A psychiatric condition that would preclude or take precedence over study participation (e.g., active psychosis, suicidal ideation).
- •Major sensory or motor impairment that would preclude valid cognitive testing secondary to inability to complete study procedures (e.g., blindness, paresis).
- •IQ < 70 based on standardized testing routinely conducted on primary treatment protocols or as part of the New Oncology Program in Psychology (NOPP).
- •Metal or surgical implants that would prevent MRI scanning.
- •Inability or unwillingness of research participant or legal guardian/ representative to give written informed consent.
- •Pregnancy. The St. Jude IRB requires that a female participant of childbearing potential (generally >10 yrs. old) must have a negative pregnancy test as a condition of clinical research eligibility.
- •Permanent orthodontic retainers or braces-shunt, anything else that would not be a safety risk but would impact image quality.
研究组 & 干预措施
DLPFC Neurofeedback Group
Participants receive real-time fMRI neurofeedback targeting the dorsolateral prefrontal cortex (DLPFC) to train working memory-related brain activity.
干预措施: rt fMRI Neurofeedback (DLPFC) (Behavioral)
PAC Neurofeedback Group
Participants receive real-time fMRI neurofeedback targeting the primary auditory cortex (PAC). This serves as an active control to account for non-specific effects of neurofeedback and scanner exposure.
干预措施: rt fMRI Neurofeedback (PAC) (Behavioral)
结局指标
主要结局
Enrollment Rate Among Approached Survivors (%)
时间窗: Assessed at 3 years
The enrollment rate will be calculated as the percentage of eligible medulloblastoma survivors approached for study participation who provide consent/assent and enroll in the study. A rate of 60% or greater will indicate adequate participant interest and support study feasibility.
Hemo-NFB Training Completion Rate Among Randomized Participants (%)
时间窗: Assessed at 3 years
Percentage of randomized participants who complete at least 2 of the 3 scheduled Hemo-NFB training sessions, including N-back tasks, neurocognitive assessments, and side effects evaluations. A completion rate of 60% or greater will support the feasibility of the intervention.
Rate of Training-Related Side Effects Among Randomized Participants (%)
时间窗: Assessed at 3 years
Percentage of randomized participants who experience neurofeedback training-related side effects, defined as a ≥200% increase from the pre-training assessment on at least 2 of the 3 neurofeedback training days. Side effects will be assessed using the Child Simulation Sickness Questionnaire (CSSQ), a 7-item measure of simulator-related symptoms across nausea, oculomotor symptoms (e.g., eye strain), and disorientation (e.g., dizziness). Each item is rated on a 3-point scale (0 = No, 1 = A little, 2 = A lot). A lower percentage of participants meeting the side-effect criterion indicates greater acceptability of the intervention.
次要结局
- Change in Bilateral DLPFC Modulation During fMRI Neurofeedback (% BOLD Signal Change, mean ± SD)(Assessed at 3 years)
- Change in Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF-2) Score (mean ± SD)(Assessed at 3 years)
- Change in Age-Standardized Wechsler Working Memory Index Score (mean ± SD)(Assessed at 3 years)