Monitoring Neurocognitive Dysfunction and the Impact of Metabolism and Physical Capacity After Paediatric HSCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Stem Cell Transplant, Late Effect, Neurocognitive Dysfunction, Paediatric Patients. Basic parameters: from 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Monitoring Neurocognitive Dysfunction and the Impact of Metabolism and Physical Capacity After Paediatric Haematopoietic Stem Cell Transplantation (Abbreviation: MindMe)
Overview
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.
Primary outcome measures
- Intelligence quotient [Time frame: Day 1]
- verbal reasoning [Time frame: Day 1]
- verbal learning [Time frame: Day 1]
- non-verbal reasoning [Time frame: Day 1]
- working memory [Time frame: Day 1]
- executive functioning [Time frame: Day 1]
- sustained attention [Time frame: Day 1]
- processing speed [Time frame: Day 1]
- fine motor skills [Time frame: Day 1]
Secondary outcome measures (12)
- Waist circumference [Time frame: Day 1]
- Triglycerides [Time frame: Day 1]
- HDL-cholesterol [Time frame: Day 1]
- Fasting glucose [Time frame: Day 1]
- Blood pressure [Time frame: Day 1]
- Hip circumference [Time frame: Day 1]
- Test of lower extremity isometric knee extension strength [Time frame: Day 1]
- Handgrip strength [Time frame: Day 1]
- Muscle performance: Timed-up-and-go [Time frame: Day 1]
- Muscle performance: Sit-to-stand 30 sec. [Time frame: Day 1]
- Muscle performance: Sit-to-stand 60 sec. [Time frame: Day 1]
- Cardiorespiratory fitness [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- =/> 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.
Exclusion criteria
- diagnosed with infantile autism before their HSCT
- Downs Syndrome
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Denmark · 1 center
- Rigshospitalet — Copenhagen
Identifiers
NCT: NCT07140445 · MindMe