Monitoring Neurocognitive Dysfunction and the Impact of Metabolism and Physical Capacity After Paediatric Haematopoietic Stem Cell Transplantation (Abbreviation: MindMe)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Intelligence quotient
研究概览
简要总结
Today the overall survival of childhood cancers has increased to above 85%. This increase is partially caused by treatment with bone marrow transplantation. A bone marrow transplantation is an efficient treatment against high-risk leukemia, as well as other life-threatening immunological and hematological diseases. However, it is unfortunately also related to the risk of developing a long series of late effects during early adulthood, such as reduced muscle mass, cardiovascular disease and diabetes.
Some survivors of bone marrow transplantation in childhood also seem to experience changes in cognitive functions. These changes may be experienced as difficulties with concentration, forgetfulness, learning difficulties, and challenges in school or the labour market. Currently, the extent of cognitive changes following bone marrow transplantation in childhood is not fully understood, nor how it relates to other late effects, and what can be done to prevent cognitive impairment.
This research project will examine cognitive function in a group of survivors of bone marrow transplantation in childhood and find out whether there is a correlation between reduced cognitive function and the occurrence of other late effects, including metabolic changes and reduced physical capacity. It will also explore associations between cognitive function at late follow up and blood-based biomarkers of neurological damage and systemic inflammation at the time of transplantation to identify predictors of reduced cognitive function.
The goal of the study is to evaluate the level of cognitive functioning after bone marrow transplantation in childhood, see how it relates to other late effect and identify risk factors and biomarkers in the blood that can predict which patients are at risk of neurocognitive impairment. The results of this study will hopefully contribute to optimizing the prevention and treatment of cognitive impairments following bone marrow transplantation in childhood, thereby improving the quality of life for survivors of bone marrow transplantation in childhood.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •=/> 7 years of age
- •treatment with HSCT in Denmark since 2010
- •treatment with HSCT was before the age of 18 years
- •ability to speak and understand Danish.
排除标准
- •diagnosed with infantile autism before their HSCT
- •Downs Syndrome
结局指标
主要结局
Intelligence quotient
时间窗: Day 1
Scored on the clinical neurocognitive tests Wechler Intelligence Scale for Children Fifth edition (WISC-V ) for participants 7-16.9 years of age and Wechler Adult Intelligence Scale Fourth edition (WAIS-IV) for participants 17 years of age or older. Scaled scores range from 0-19, higher = better performance.
verbal reasoning
时间窗: Day 1
Scored on the clinical neurocognitive tests Wechler Intelligence Scale for Children Fifth edition (WISC-V ) for participants 7-16.9 years of age and Wechler Adult Intelligence Scale Fourth edition (WAIS-IV) for participants 17 years of age or older. Scaled scores range from 0-19, higher = better performance.
verbal learning
时间窗: Day 1
Assessed by a neuropsychologist using Test of Memory and Learning, second edition (TOMAL--2) and Rey Complex Figure Test and Recognition Trial (RCFT). TOMAL-2 scores are age-based scaled scores; higher scores reflect better verbal memory performance. Scores for RCFT range from 0-36 with higher scores reflecting better visual memory.
non-verbal reasoning
时间窗: Day 1
Scored on the clinical neurocognitive tests Wechler Intelligence Scale for Children Fifth edition (WISC-V ) for participants 7-16.9 years of age and Wechler Adult Intelligence Scale Fourth edition (WAIS-IV) for participants 17 years of age or older. Scaled scores range from 0-19, higher = better performance.
working memory
时间窗: Day 1
Scored on the clinical neurocognitive tests Wechler Intelligence Scale for Children Fifth edition (WISC-V ) for participants 7-16.9 years of age and Wechler Adult Intelligence Scale Fourth edition (WAIS-IV) for participants 17 years of age or older. Scaled scores range from 0-19, higher = better performance.
executive functioning
时间窗: Day 1
Assessed by a neuropsychologist using Delis-Kaplan Executive Function System (D-KEFS) trailmaking test and verbal fluency test. D-KEFS subtests yield age-based scaled scores. Higher scores indicate better executive functioning.
sustained attention
时间窗: Day 1
Assessed by a neuropsychologist using Conners' Continuous Performance Test 3rd Edition (CPT-3). The test evaluates attention-related performance in areas of inattentiveness, impulsivity, sustained attention, and vigilance. Scaled scores (t-scores) range from 0-100, higher = better performance.
processing speed
时间窗: Day 1
Scored on the clinical neurocognitive tests Wechler Intelligence Scale for Children Fifth edition (WISC-V ) for participants 7-16.9 years of age and Wechler Adult Intelligence Scale Fourth edition (WAIS-IV) for participants 17 years of age or older. Scaled scores range from 0-19, higher = better performance.
fine motor skills
时间窗: Day 1
Assessed by a neuropsychologist using Delis-Kaplan Executive Function System (D-KEFS) trailmaking test. D-KEFS subtests yield age-based scaled scores. Higher score indicates better fine motor skills
次要结局
- Waist circumference(Day 1)
- Triglycerides(Day 1)
- HDL-cholesterol(Day 1)
- Fasting glucose(Day 1)
- Blood pressure(Day 1)
- Hip circumference(Day 1)
- Test of lower extremity isometric knee extension strength(Day 1)
- Handgrip strength(Day 1)
- Muscle performance: Timed-up-and-go(Day 1)
- Muscle performance: Sit-to-stand 30 sec.(Day 1)
- Muscle performance: Sit-to-stand 60 sec.(Day 1)
- Cardiorespiratory fitness(Day 1)
- Maximal leg extension power(Day 1)
- Pediatric Quality of Life Inventory (PedsQL™) 4.0 Generic Core Scales - Child and Parent Report(Day 1)
- Pediatric Quality of Life Inventory (PedsQL™) Multidimensional Fatigue Scale - Child and Parent Report(Day 1)
- Cognitive functioning measured by the PROMIS® Cognitive Function Short Form 8a - Self-Report(Day 1)
- Physical activity measured by the PROMIS® Physical Activity Short Form 4a - Self-Report(Day 1)
- Emotional and behavioral functioning measured by the Strengths and Difficulties Questionnaire (SDQ)(Day 1)
- Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)(Day 1)
- Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) score(Day 1)
研究者
Hilde Hylland Uhlving
Principal Investigator
Rigshospitalet, Denmark