Clinical trial · Interventional
Neuropsychological Impairment and Quality of Life in Neurofibromatosis Type 1
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective of the study is to investigate the determinants of the quality of life in children and adults with Neurofibromatosis type 1 (NF1) and more particularly the specific impact of neuropsychological deficits. In fact, cognitive impairment is currently considered as one of the most pervasive features of this genetic disorder but its relationship with the worsening of quality of life found in this population has not been directly investigated to date. Secondary objectives of this study are (i) to compare neuropsychological and quality of life measures between patients and healthy controls matched by age, gender and education level, (ii) to contrast neuropsychological deficits incidence between patients and controls, and (iii) to differentiate NF1 children's self versus hetero-assessment of quality of life. The main hypothesis of this study is that the neuropsychological impairment classically identified in this clinical population will be associated to the quality of life's worsening both in children and adults.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurofibromatosis Type 1 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neuropsychological examination and quality of life measures | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patients with NF1
- interventionNames
- Other: Neuropsychological examination and quality of life measures
- type
- OTHER
- label
- Healthy controls
- interventionNames
- Other: Neuropsychological examination and quality of life measures
Primary outcomes (1)
- measure
- Quality of life as measured by the questionnaires used in children and adults
- timeFrame
- at day 0 for adults; at 4 weeks for children
- description
- Several domains in relation with quality of life (self perception, well-being, social life, emotions, etc.)
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria for Patients : * NF1 diagnosis following National Institutes of Health criteria (1988) * Age: 8-12 years for children, 18-59 years for adults * Signed informed written consent (parent and patient for children, patient for adults) * French speaking * Resident in France Inclusion Criteria for Healthy controls: * Absence of NF1 diagnosis, learning disabilities, intellectual precocity * Age: 8-12 years for children, 18-59 years for adults * Signed informed written consent (parent and healthy control for children, healthy control for adults) * French speaking * Resident in France Exclusion Criteria: * Uncorrectable hearing of visual impairment * History of psychiatric illness * Neuropsychological investigation in the last 6 months * Insufficient language usage * Any other known history of central nervous system pathology or neuropathological complications of NF1
References
Publications (0)
Data not yet available