Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Direct Testing of Executive Function: Change in Working Memory from baseline to 6 months
研究概览
简要总结
Long-term survivors of ALL are at-risk for neurocognitive impairment, particularly in the area of executive functioning. Relatively limited research has focused on interventions for improving neurocognitive outcomes in long-term survivors of ALL. A promising technique for cognitive enhancement is Transcranial Direct Current Stimulation (tDCS) which differs from conventional cognitive remediation approaches in that it directly stimulates specific brain regions responsible for cognitive processes and activates functional networks similar to those activated during cognitive training.
Primary Objective
To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS) paired with remote cognitive training on direct testing of executive function in survivors of ALL.
Secondary Objectives
- To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS) paired with remote cognitive training on patient-reported symptoms of executive dysfunction in survivors of ALL.
- To examine the effects of home-based tDCS paired with remote cognitive training on patterns of regional brain activation as measured by functional magnetic resonance imaging.
- To examine the effects of home-based tDCS paired with remote cognitive training on white matter integrity and structure as measured by diffusion tensor imaging.
详细描述
Eligible participants will be randomized to receive 1 mA direct current stimulation over the left dorsolateral prefrontal cortex or placebo/sham for 20 minutes. All participants will receive home-based computerized cognitive training. Participants will complete tDCS paired with cognitive training 2 times per week for 6-months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed treatment for acute lymphoblastic leukemia (ALL) at SJCRH < 21 years at diagnosis
- •Enrolled on St. Jude Lifetime Cohort Study
- •≥ 5 years post-diagnosis of ALL
- •≥ 2 years post-treatment completion deemed to impact the central nervous system.
- •Currently between 18 and 39 years of age
- •English language proficiency
- •Executive dysfunction defined as having an age-adjusted standard score <16th percentile on Trail Making Test Part B, Controlled Oral Word association Test, or Digit Span Backward
- •Patient-reported executive dysfunction defined as a standard score >84th percentile on the Childhood Cancer Survivor Study Neurocognitive Questionnaire or the Behavior Rating Scale of Executive Function
排除标准
- •Full scale intelligence score <80
- •Currently taking medication intended to treat neurocognitive impairment (e.g. stimulants)
- •Participated in a past trial of neurostimulation
- •Female who is pregnant or breastfeeding
- •History of seizures within the past year
- •Implanted medical devices or metal in the head
- •History of head injury or a neurodevelopmental disorder (i.e. genetic disorder, hypoxic-ischemic encephalopathy) associated with neurocognitive impairment and unrelated to cancer treatment
- •Currently receiving cancer directed therapy
结局指标
主要结局
Direct Testing of Executive Function: Change in Working Memory from baseline to 6 months
时间窗: Baseline & 6-month follow-up
Digit Span Backward: Digit Span Backward (DSB), from the Digit Span subtest on the WAIS-IV, is a measure of working memory. The number of digits recalled in the longest span is converted to a standard z-score using age-based norms (Mean=0, SD=1).
Direct Testing of Executive Function: Change in Verbal Fluency from baseline to 6 months
时间窗: Baseline & 6-month follow-up
Controlled Oral Word Association (COWA): This is a task of cognitive/verbal fluency that measures spontaneous production of words beginning with a designated letter or category. Age-based standardized z-scores are calculated (Mean=0, SD=1).
Direct Testing of Executive Function: Change in Cognitive Flexibility in baseline to 6 months
时间窗: Baseline & 6-month follow-up
Trail Making Test Part B (Trails B): This is a timed task that requires a participant to shift his/her attention adaptively and flexibly. Age-based standardized z-scores are calculated (Mean=0, SD=1).
次要结局
- Change in Brain Connectivity from baseline to 6 months(Baseline and 6-month follow-up)
- Change in Regional Brian Activation from baseline to 6 months(Baseline and 6-month follow-up)
- Change in Patient-Reported Symptoms of Executive Functioning from baseline to 6 months(Baseline and 6-month follow-up)