Transcranial Direct Current Stimulation of the Temporal Cortex in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Number of participants who completed three sessions of tDC stimulation and cognitive testing.
研究概览
简要总结
Brief Overview: Children and adolescents diagnosed with cancer will experience problems with learning, memory and attention during and after completing their cancer therapy. There are many factors that contribute to this problem, but investigators have recently identified that chemotherapy agents used in treating Acute Lymphoblastic Leukemia (ALL) may disrupt normal brain development.
A novel device has been developed that may help correct this disruption. Direct Current Stimulation (DCS) uses a very low level of constant electrical current to stimulate specific parts of the brain. It has been used in patients with stroke to great benefit. Our study at St. Jude Children's Research Hospital is designed to see if this technique will benefit survivors of childhood cancer. Specifically, investigators wish to see if stimulating one part of the brain gives a greater benefit than stimulating another part of the brain.
Primary Objective
Evaluate the feasibility of conducting repeated on-site Transcranial Direct Current Stimulation (tDCS) in children who are long-term survivors of
Secondary Objectives
- To estimate the potential efficacy for powering a future larger study using tDCS to improve cognitive performance in children by suppressing over connected neural hubs in long-term survivors of childhood ALL.
- To compare the performance of anodal stimulation of the frontal lobe to cathodal suppression of the superior temporal lobe on cognitive performance.
详细描述
Participants will be randomly assigned to one of three intervention arms. Two brief stimulation periods will be conducted on day one. One brief stimulation will be scheduled in the morning and a second brief stimulation will be scheduled in the afternoon. A final stimulation will be conducted on day two. Direct Current Stimulation will be applied for 20 minutes for each stimulation period. Brief neurocognitive testing will be conducted during each stimulation session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 215 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ALL survivors who received chemotherapy-only treatment and are enrolled in SJLIFE.
- •8-17 years old.
- •History of executive function, processing speed and/or memory impairment documented as a score < 10th percentile of the age adjusted Z-score.
- •Participants able to speak and understand the English language.
排除标准
- •Survivors who received cranial radiation.
- •Survivors with a Full-Scale IQ <
- •Pregnant, history of migraines, epilepsy or traumatic brain injury.
- •Have a scalp or skin condition (e.g., psoriasis or eczema), metallic implants (except for dental fillings or caps) or retained metal fragments.
- •History of neurologic condition or genetic disorder associated with neurocognitive impairment unrelated to cancer diagnosis or treatment.
- •Not fluent in English.
- •Taking a psychoactive drug or stimulant.
结局指标
主要结局
Number of participants who completed three sessions of tDC stimulation and cognitive testing.
时间窗: 12 months after participant enrollment
The trial will be considered feasible if at least 30 survivors are able to complete 3 sessions (tDCS along with cognitive testing).
次要结局
- Grooved peg board test (GPB)(48 hours)
- Bushke selective remining test (BSRT)(48 hours)
- NIH toolbox flanker inhibitory control and attention test (Flanker)(48 hours)
- NIH toolbox list sorting working memory test (WM)(48 hours)