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Stem Cell TransplantMindMeNCT07140445

Monitoring Neurocognitive Dysfunction and the Impact of Metabolism and Physical Capacity After Paediatric HSCT

An observational study of Stem Cell Transplant and Late Effect, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 7 years and older
How many people
175 participants
Where
1 siteDenmark
Study dates
1 Sep 2025to 1 Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Participants: All survivors of paediatric HSCT in Denmark who have undergone transplantation since 2010, being at least 2 years after HSCT, and at least 7 years of age on the day of assessment are eligible. All participants must be able to speak and understand Danish as well as to understand the research project, to give informed consent to participate. For participants younger than 18 years, where the parents will give consent, at least one parent must speak Danish. Thus, the inclusion criteria are: at least 7 years of age, treatment with HSCT in Denmark since 2010 before the age of 18 years, and ability to speak and understand Danish. Exclusion criteria: Participants who were diagnosed with infantile autism before their HSCT or have Downs Syndrome will be excluded from the study.

Who may be able to join

  • =/> 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.

Who cannot join

  • diagnosed with infantile autism before their HSCT
  • Downs Syndrome

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hilde H Uhlving, MD, PhD contact

+45 35451356

hilde.hylland.uhlving@regionh.dk

Denmark1 site
  • Rigshospitalet

    Copenhagen, Capital Region, 2100

    Hilde H Uhlving, MD, PhD, +45 35451356, hilde.hylland.uhlving@regionh.dk

    Nanna Eriksen, MD, +45 30275694, nanna.eriksen.02@regionh.dk

Other trials in Denmark

About this study

Official title: Monitoring Neurocognitive Dysfunction and the Impact of Metabolism and Physical Capacity After Paediatric Haematopoietic Stem Cell Transplantation (Abbreviation: MindMe)

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.

Read more

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.

Medical subject headings
Cognition Disorders, Metabolic Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intelligence quotient

    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.

    Measured: Day 1

  2. verbal reasoning

    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.

    Measured: Day 1

  3. verbal learning

    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.

    Measured: Day 1

  4. non-verbal reasoning

    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.

    Measured: Day 1

  5. working memory

    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.

    Measured: Day 1

  6. executive functioning

    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.

    Measured: Day 1

  7. sustained attention

    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.

    Measured: Day 1

  8. processing speed

    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.

    Measured: Day 1

  9. fine motor skills

    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

    Measured: Day 1

Secondary outcomes (20)
  1. Waist circumference

    Waist circumference will be measured at the level of the superior border of the iliac crest, at the end of a normal expiration with a tape measure to the nearest 0.1 cm, as suggested by The US National Cholesterol Education Programme. Patients will be classified according to the American Heart Association/National Heart, Lung, and Blood Institute (AHA/NHLBI) criteria for Metabolic Syndrome as defined in the 2005 scientific statement (Grundy et al., 2005).

    Measured: Day 1

  2. Triglycerides

    Blood samples will be drawn from a cannula placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to the American Heart Association/National Heart, Lung, and Blood Institute (AHA/NHLBI) criteria for Metabolic Syndrome as defined in the 2005 scientific statement (Grundy et al., 2005).

    Measured: Day 1

  3. HDL-cholesterol

    Blood samples will be drawn from a cannula placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to the American Heart Association/National Heart, Lung, and Blood Institute (AHA/NHLBI) criteria for Metabolic Syndrome as defined in the 2005 scientific statement (Grundy et al., 2005).

    Measured: Day 1

  4. Fasting glucose

    Blood samples will be drawn from a cannula placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to the American Heart Association/National Heart, Lung, and Blood Institute (AHA/NHLBI) criteria for Metabolic Syndrome as defined in the 2005 scientific statement (Grundy et al., 2005).

    Measured: Day 1

  5. Blood pressure

    Blood pressure will be measured on the upper arm while sitting in the suppine position, after 10 minutes of rest, with an automated blood pressure monitor. Blood pressure will be measured three times, or untill there is less than 10 mmHg difference between measurements. The final blood pressure will be a mean of the two last measurements. Patients will be classified according to the American Heart Association/National Heart, Lung, and Blood Institute (AHA/NHLBI) criteria for Metabolic Syndrome as defined in the 2005 scientific statement (Grundy et al., 2005).

    Measured: Day 1

  6. Hip circumference

    Measurement of hip circumference at the widest part of the buttocks with a tape measure, to the nearest 0.1 cm.

    Measured: Day 1

  7. Test of lower extremity isometric knee extension strength

    Test of lower extremity isometric knee extension strength: will be assessed by measuring the rate of force development, maximal isometric force, and dynamic force capacity using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany) and amplifier. Data is collected through an AD-card (100 HZ) with customized software (LabVIEW ®, National Instruments, Texas, USA). The participant will be seated during the test. The participant's thigh, pelvis, and torso will be securely strapped to minimize movement and isolate the knee extension muscles. For the isometric test, the participant will be instructed to push against the lever arm of the dynamometer as hard and as quickly as possible for a few seconds without any movement at the knee joint.

    Measured: Day 1

  8. Handgrip strength

    Handgrip strength will be measured while standing, with the elbow free from the body and flexed 90 degrees. Participants will press as hard as possible on a handheld dynamometer. Handgrip strength (kg) is measured twice for both arms and the highest result will be used in the analyses. Handgrip strength is a measure of strength in the underarm and correlate with overall physical impairment.

    Measured: Day 1

  9. Muscle performance: Timed-up-and-go

    Participants will sit on a chair with both feet flat on the ground. Subsequently, participants will be instructed to stand up, walk 3 meters, turn around, walk back, and sit down as fast as possible. Each participant will perform the test three consecutive times and the fastest test will be used for the analyses. The timed-up-and-go test depends on lower body muscular strength and balance and reflects a person's ability to move in an everyday setting.

    Measured: Day 1

  10. Muscle performance: Sit-to-stand 30 sec.

    Sit-to-Stand 30 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 30 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome.

    Measured: Day 1

  11. Muscle performance: Sit-to-stand 60 sec.

    Sit-to-Stand 60 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 60 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome.

    Measured: Day 1

  12. Cardiorespiratory fitness

    performed on an electrical-break ergometer bicycle (Lode Corival Pediatric or Monark Ergomedic 839 E) using a modified Godfrey protocol. The participant will be instructed to keep a steady pace (70-80 rpm), while the workload increases gradually with 10-25 watts pr. minute until exhaustion. Oxygen uptake (VO2), heart rate (HR), minute ventilation (VE), respiratory exchange ratio (RER), breathing frequency (BF), and tidal volume (TV) will be measured continuously during the test using a transportable a portable Cortex Metamax 3B wireless spirometry system (Cortex, Leipzig, Germany). The participant will breathe into a Hans Rudolph Valve (2-wat NRBV, Hans Rudolph Inc., Kansas City, MO, USA). Heart rate and oxygen saturation will be measured during the test. Furthermore, two objective criteria need to be fulfilled before the test is valid: 1) heart rate >85% of estimated maximal heart rate 2) respiratory exchange ratio (RER)>1.1. The primary outcome will be the peak oxygen uptake (V02max

    Measured: Day 1

  13. Maximal leg extension power

    Maximal leg extension power: maximal voluntary muscle force will be measured from both legs following a fixed protocol. Leg extensor power will be measured using an extension Power Rig (Nottingham Power Rig, Queen's Medical Centre Nottingham, NG7 2UH, United Kingdom), with subjects positioned with joint angles as if the participant was rising from a chair. Participants are carefully instructed to keep their hands across the chest and to not move the upper body while pushing. Verbal encouragement will be given to ensure maximal performance. The participants extend one leg as forcefully as possible, and the velocity of the flywheel is measured by an opto-switch and used to calculate average leg extensor power in the push. Dominant leg will be tested, a minimum of 5 attempts is carried out for each leg, however the participant continues until two attempts are lower than the maximum. The result is expressed in watt (W).

    Measured: Day 1

  14. Pediatric Quality of Life Inventory (PedsQL™) 4.0 Generic Core Scales - Child and Parent Report

    The PedsQL 4.0 Generic Core Scales assess health-related quality of life in children across four domains: physical functioning, emotional functioning, social functioning, and school functioning. The instrument uses a 5-point Likert scale (0 = never a problem; 4 = almost always a problem) - lower score meaning better outcome.

    Measured: Day 1

  15. Pediatric Quality of Life Inventory (PedsQL™) Multidimensional Fatigue Scale - Child and Parent Report

    The PedsQL Multidimensional Fatigue Scale assesses fatigue in children in three domains: general fatigue, sleep/rest fatigue, and cognitive fatigue. It uses the same 5-point Likert scale (0 = never a problem; 4 = almost always a problem) - lower score meaning better outcome.

    Measured: Day 1

  16. Cognitive functioning measured by the PROMIS® Cognitive Function Short Form 8a - Self-Report

    The PROMIS® Cognitive Function Short Form 8a is an 8-item self-report questionnaire assessing perceived cognitive functioning in the past 7 days. It evaluates aspects such as memory, mental clarity, and concentration. Each item is scored on a 5-point Likert scale ranging from 1 ("very often") to 5 ("never") - higher scores indicate better subjective cognitive functioning.

    Measured: Day 1

  17. Physical activity measured by the PROMIS® Physical Activity Short Form 4a - Self-Report

    The PROMIS® Physical Activity Short Form 4a is a 4-item self-report questionnaire that assesses the frequency and intensity of physical activity during the past 7 days. Items are rated on a 5-point Likert scale, with higher scores indicating higher levels of physical activity.

    Measured: Day 1

  18. Emotional and behavioral functioning measured by the Strengths and Difficulties Questionnaire (SDQ)

    The Strengths and Difficulties Questionnaire (SDQ) is a brief screening tool used to assess emotional and behavioral functioning. It consists of 25 items covering five subscales: Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, Peer Relationship Problems, and Prosocial Behavior. Each item is rated on a 3-point scale: "Not true" (0), "Somewhat true" (1), or "Certainly true" (2). A Total Difficulties Score (0-40) is calculated by summing four of the five subscales (excluding Prosocial Behavior), where higher scores indicate more emotional or behavioral difficulties. Higher Prosocial scores (0-10) indicate better social functioning.

    Age-appropriate versions of the SDQ will be used: parent- and self-report forms for children and adolescents, and self-report form for participants aged 18 years and older.

    Measured: Day 1

  19. Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

    The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2), is a standardized questionnaire assessing executive functions in everyday settings through parent or teacher reports. The questionnaire consist of 63 items (rated 1= never, 2 = sometimes, 3 = always). Higher scores indicate greater executive dysfunction.

    Measured: Day 1

  20. Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) score

    The Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) is a standardized questionnaire used to assess the severity of ADHD symptoms based on parent or teacher reports. Scores are calculated using standardized methods and normed according to Danish age- and gender-specific normative data. The scale consists of items rated on a 4-point scale (0 = never or rarely 3 = very often). Higher scores indicate greater severity of ADHD symptoms.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
175 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07140445
Sponsor's protocol ID
MindMe
Acronym
MindMe
Status last verified
Aug 2025
First submitted
24 Jul 2025
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stem Cell Transplant and Late Effect, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hilde H Uhlving, MD, PhD (+45 35451356, hilde.hylland.uhlving@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intelligence quotient (time frame: Day 1). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.

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