Moyamoya DiseaseTFMoya : ADARNCT05772572
Functional Disorders Moya Moya Young Patients
An observational study of Moyamoya Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Moya Moya disease is a rare condition of the vessels that supply blood to the brain. It normally occurs without apparent cause. In both children and adults, the disease is mainly manifested by strokes. Diagnosis is made on MRI and cerebral angiography. Read more about this study
- Who is it for?
- Ages 7 to 25 years
- Conditions the study is for
- Moyamoya Disease
- What is being tested?
- Questionnaires
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2023to 9 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The cohort will be selected from the Necker Hospital cohort (child neurology and neurosurgery services).
Who may be able to join
- Adult patients up to 25 years old and minor patients aged 7 to 17 inclusive and holders of parental authority for minor patients
- Patients operated (or re-operated) for a Moya Moya in the previous 7 years
- Subjects without intellectual disabilities
- Subjects speaking French well enough to answer the questions of the study
- subjects (parent(s) and minor or adult patient) and holders of parental authority informed and who do not object to their participation in the study
Who cannot join
- Cognitive level of the patient incompatible with the administration of the questionnaires and evaluations of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Disorders in the MoyaMoya Disease of Children, Adolescents and Young Adults: Place of Anxiety, Depression, Attachment of the Child and Parents, and Representations of Illness and Child Surgery
Moya Moya disease is a rare condition of the vessels that supply blood to the brain. It normally occurs without apparent cause. In both children and adults, the disease is mainly manifested by strokes. Diagnosis is made on MRI and cerebral angiography. There is no treatment that can prevent the arteries in the brain from narrowing.
Surgical treatment may be a priority, especially in the early forms of the disease. Functional, painful disorders, in particular headaches, may persist after neurosurgical intervention, without any clear predictive factor being found. Otherwise there is a disjunction between the objectification of sequelae on MRI and painful complaints, sometimes a dissociation between the improvement of the objective parameters of perfusion and imaging, and functional somatic complaints.
The study focuses on improving knowledge of post-operative functional disorders in Moya Moya disease in children and adolescents, in order to propose interventions based on this knowledge and making it possible to reduce both functional complaints and depression, the anxiety which accompanies them, to decrease the impact on the quality of life and parental wandering in the installation of adapted accompaniments. For this, a half-day consultation will be intended in order to carry out questionnaires and standardized tests, the results of which will be reported and compared to known rates in the general population and the population of children with chronic diseases.
Read the detailed description
Moya Moya disease is a rare condition of the vessels that supply blood to the brain. It normally occurs without apparent cause. In both children and adults, the disease is mainly manifested by strokes. Diagnosis is made on MRI and cerebral angiography. There is no treatment that can prevent the arteries in the brain from narrowing.
Surgical treatment can be considered, especially in the early forms of the disease. Several surgical techniques are used to divert the vessels, including multiple craniotomies, which consists of making several small holes in the cranium so as to pass vessels from the scalp so that they develop towards the poorly irrigated areas of the brain.
Functional, painful disorders, in particular headaches, can persist after neurosurgical intervention, without any clear predictive factor being found. 57% of patients under 17 with Moya Moya disease have persistent functional disorders in without correlation to any of the characteristics of the disease, nor to its surgical treatment. There is a disjunction between the objectification of sequelae on MRI and painful complaints, sometimes a dissociation between the improvement of the objective parameters of perfusion and imaging, and functional somatic complaints. Interviews with families experienced that psychological phenomena may play an important role in postoperative pain and functional complaints: child and parent anxiety, depression, and family functioning and attachment, child cognitive functioning.
Functional complaints and postoperative pain are therefore frequent in children and adolescents with Moya Moya, but poorly documented. The difficulty is to be able to disentangle the pain linked to organic factors such as a recurrence of a vascular accident, and those linked to psychological factors, as they have been described in the disease. The important thing is to be able to avoid or reduce paraclinical explorations in the face of the resurgence of painful complaints; the challenge is to defuse the vicious interactive circle between painful complaints, anxiety-provoking explorations, reinforcing stress and possible increase complaints. Identifying the psychological factors would make it possible to better support functional complaints.
The study focuses on improving knowledge of post-operative functional disorders in Moya Moya disease in children and adolescents, in order to propose interventions based on this knowledge and making it possible to reduce both functional complaints and depression, the anxiety which accompanies them, to decrease the impact on the quality of life and parental wandering in the installation of adapted accompaniments. For this, a half-day consultation will be intended in order to carry out questionnaires and standardized tests, the results of which will be reported and compared to known rates in the general population and the population of children with chronic diseases.
- Conditions
- Moyamoya Disease
- Being tested
- Questionnaires
- Keywords
- Moyamoya Disease, Anxiety, Depression, Parent-child attachment, Psychological representations of illness and surgery
- Medical subject headings
- Moyamoya Disease, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Questionnaires are completed only once and assess:
- recorded questions about the disease and the operation for the parents and the patient, human figure drawing test and drawing of the operation for the patient
- psychiatric questionnaires for parents and patients on anxiety and depression
- behavior questionnaires for the parents and the patient: assessment of attachment
- questionnaires for the parents and the patient concerning the family context, the quality of life
| Study group | Role | What they receive |
|---|---|---|
| Patients | Children aged 7 to 17 inclusive, and young adults operated (or re-operated) for a Moya Moya in the previous 7 years and followed at the Necker-Enfants Malades hospital, and their parents. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
The " State trait anxiety inventory ", STAI forme Y
Study the links between postoperative functional disorders by multiple craniotomies in children and adolescents with Moya Moya disease, and psychological dimensions such as anxiety.
For teenager, adults patients and parents : The " State trait anxiety inventory ", STAI form Y (revised), a self-questionnaire assessing trait anxiety (usual tendency to be anxious) and state anxiety (anxiety felt at a particular time), has 20 items for assessing trait anxiety and 20 for state anxiety on a 4-point Likert scale, scores range from 20 to 80, with higher scores correlating with greater anxiety.
Measured: Day 0
Revised Children's Manifest Anxiety Scale (RCMAS)
Revised Children's Manifest Anxiety Scale (RCMAS) : self-administered 37-item questionnaire assessing the level and nature of anxiety in children and adolescents aged 9 to 19, not allowing diagnosis of the various anxiety disorders in children. The total anxiety score can range from 0 to 28. The cut-off point for pathological anxiety is more than two standard deviations around the mean (T more than 70).
Measured: Day 0
Children Depression Inventory (CDI)
Study the links between postoperative functional disorders by multiple craniotomies in children and adolescents with Moya Moya disease, and psychological dimensions such as depression.
CDI Children Depression Inventory : self questionnaire of 27 items which measures the intensity of depression in children and adolescents from 7 to 17 years old. Each item is rated from 0 (normal behavior for age or absent) to 2 (severe). The addition of the items gives a total between 0 and 54. The higher the score, the more severe the depression symptomatology is.
Measured: Day 0
Beck = Depression
Parents and young adult patients : Beck = Depression Multiple-choice questionnaire of 21 items of symptoms and attitudes, used to measure the severity of clinical depression, graded from 0 to 3 by a series of 4 statements (from 0 to 63, higher score correlating with higher severity) reflecting the degree of severity of the symptom.
Measured: Day 0
FMSS= Five minute speech sample, quality of the parent-child relationship
The Five Minute Speech Sample (FMSS) is a method that can be used to measure both expressed emotion and narrative coherence. The FMSS requires parents to speak about their child and their relationship with their child for five minutes. The final coding assesses one of two categories: high Expressed Emotions (H EE), or Low Expressed Emotions (Low EE).
Measured: Day 0
Cards for the evaluation of Attachment and Mentalization in Children (CAME)
Study the links between postoperative functional disorders by multiple craniotomies in children and adolescents with Moya Moya disease, and psychological dimensions such as of attachment of child with parents.
CAME: Cards for the evaluation of Attachment and Mentalization in Children, from Child Attachment Interview. The final coding assesses 6 principal dimensions of attachment and 8 secondary dimensions in T quantitative scores. The T scores are scaled so that 50 is average for the youth's age and gender, with a standard deviation of 10 points. Higher scores indicate greater problems. Principal attachment dimensions: Secure (SEC), Insecure-Deactivated (DEAC), Insecure-Hyperactivated (HYP), insecure disorganized (DIS), Mentalized Attachment (MENT-A); the 8 secondary dimensions are: Coherence (COH), Reflective Self (REF-S), Access to Memories (MEM), Mentalization (MENT), Preoccupation/anger (PRE-A), Traumatism (TRAU), Need comfort (COM), Life Difficulties (LIFE-D).
Measured: Day 0
CA-MIR : cards for assessment of parent's attachment
Cards for assessment of parent's attachment. The final coding assesses 3 principal dimensions of attachment and 13 secondary dimensions in T quantitative scores. The standard scores are scaled so that 50 is average for the youth's age and gender, with a standard deviation of 10 points. Higher scores indicate greater problems.
Principal attachment dimensions: Secure (SEC), Insecure- Detached (DET), Insecure- Preoccupied (PRE); the 13 secondary dimensions are : Parental Interference (PAR-I), Family concern (FAM-C), Infantilization Grudge (INF-G), Parental support (PAR-S), Family support (FAM-S), Recognition of support (REC-SUP), Parental unavailability (PAR-UN), Family (FAM-D), Rejection Grudge (REJ-G), Parental Trauma (PAR-TR), Memory Blocking (MEM-B), Parental resignation (PAR-RE), Valuation of Hierarchy (HIE-V).
Measured: Day 0
Child Behavior Checklist (CBCL)
The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioural problems in children and adolescents.
The main scoring for the CBCL is based on statistical groupings of sets of behaviors that typically occur together.
Coding assesses 8 syndrome scales:withdrawal, somatic complaints, anxious/depressed, social problems, thought problems, attention problems, rule-breaking behaviour, aggressive behaviour, and two higher order factors: internalizing, and externalizing, and a total score.The standard scores are scaled so that 50 is average for the youth's age and gender, with a standard deviation of 10 points.
For each syndrome, Internalizing and Externalizing problem scales, and the total score, scores can be interpreted as falling in the normal, borderline, or clinical behavior.
Measured: Day 0
Representations of disease and surgery
Human figure drawing test and drawing of the operation for the patient. Recorded questions about the disease and the operation for the parents and the patient.
- For the human figure: The Royer grid will allow to define 1) quartiles for the size of the figure according to the age of the child 2) the developmental age for the figure, according to a score varying from 0 to 60.
- responses will be qualitatively analyzed to determine prevalent themes.
Measured: Day 0
Pediatric Quality of Life Inventory (PedsQL)
The Pediatric Quality of Life Inventory (PedsQL) makes it possible to assess the quality of life in relation to the state of health of healthy children or children suffering from various diseases. The 23 questions, each scoring from 0 (never) to 4 (almost always), relate to 4 different areas: the functional physical (8 items, total from 0 to 32), emotional (5 items, total from 0 to 20), social (5 items, total from 0 to 20), and school (5 items, total from 0 to 20). A total score can be calculated (from 0 to 92).
4 versions are proposed, according to the age of the child/adolescent/young adult, each scoring in the same way.
Measured: Day 0
Secondary outcomes (1)
Medical and neuropsychological assessment of patients
- association between medical parameters (history of stroke, number of surgical procedures, hypoperfusion on MR imaging, or cognitive dysfunction) and presence of functional disorders
- association between medical parameters (history of stroke, number of surgical procedures, hypoperfusion on MR imaging, or cognitive dysfunction) and anxiety (RCMAS score >70), depression (abnormal Beck score), or functional attachment (abnormal high CAME score)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start2 May 2023
- Primary completion9 Feb 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Lisa Ouss, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisManoelle Kossorotoff, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772572
- Sponsor's protocol ID
- APHP220991
- Other IDs
- 2021-A02555-36
- Acronym
- TFMoya : ADAR
- Status last verified
- Sep 2025
- First submitted
- 6 Mar 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Disorders in the MoyaMoya Disease of Children, Adolescents and Young Adults: Place of Anxiety, Depression, Attachment of the Child and Parents, and Representations of Illness and Child Surgery
- ClinicalTrials.gov ID
- NCT05772572
- Acronym / sponsor ID
- TFMoya : ADAR / APHP220991
- Conditions
- Moyamoya Disease
- Keywords
- Moyamoya Disease, Anxiety, Depression, Parent-child attachment, Psychological representations of illness and surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 2 May 2023 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Moya Moya disease is a rare condition of the vessels that supply blood to the brain. It normally occurs without apparent cause. In both children and adults, the disease is mainly manifested by strokes. Diagnosis is made on MRI and cerebral angiography. There is no treatment that can prevent the arteries in the brain from narrowing.
Surgical treatment may be a priority, especially in the early forms of the disease. Functional, painful disorders, in particular headaches, may persist after neurosurgical intervention, without any clear predictive factor being found. Otherwise there is a disjunction between the objectification of sequelae on MRI and painful complaints, sometimes a dissociation between the improvement of the objective parameters of perfusion and imaging, and functional somatic complaints.
The study focuses on improving knowledge of post-operative functional disorders in Moya Moya disease in children and adolescents, in order to propose interventions based on this knowledge and making it possible to reduce both functional complaints and depression, the anxiety which accompanies them, to decrease the impact on the quality of life and parental wandering in the installation of adapted accompaniments. For this, a half-day consultation will be intended in order to carry out questionnaires and standardized tests, the results of which will be reported and compared to known rates in the general population and the population of children with chronic diseases.
Detailed description
Moya Moya disease is a rare condition of the vessels that supply blood to the brain. It normally occurs without apparent cause. In both children and adults, the disease is mainly manifested by strokes. Diagnosis is made on MRI and cerebral angiography. There is no treatment that can prevent the arteries in the brain from narrowing.
Surgical treatment can be considered, especially in the early forms of the disease. Several surgical techniques are used to divert the vessels, including multiple craniotomies, which consists of making several small holes in the cranium so as to pass vessels from the scalp so that they develop towards the poorly irrigated areas of the brain.
Functional, painful disorders, in particular headaches, can persist after neurosurgical intervention, without any clear predictive factor being found. 57% of patients under 17 with Moya Moya disease have persistent functional disorders in without correlation to any of the characteristics of the disease, nor to its surgical treatment. There is a disjunction between the objectification of sequelae on MRI and painful complaints, sometimes a dissociation between the improvement of the objective parameters of perfusion and imaging, and functional somatic complaints. Interviews with families experienced that psychological phenomena may play an important role in postoperative pain and functional complaints: child and parent anxiety, depression, and family functioning and attachment, child cognitive functioning.
Functional complaints and postoperative pain are therefore frequent in children and adolescents with Moya Moya, but poorly documented. The difficulty is to be able to disentangle the pain linked to organic factors such as a recurrence of a vascular accident, and those linked to psychological factors, as they have been described in the disease. The important thing is to be able to avoid or reduce paraclinical explorations in the face of the resurgence of painful complaints; the challenge is to defuse the vicious interactive circle between painful complaints, anxiety-provoking explorations, reinforcing stress and possible increase complaints. Identifying the psychological factors would make it possible to better support functional complaints.
The study focuses on improving knowledge of post-operative functional disorders in Moya Moya disease in children and adolescents, in order to propose interventions based on this knowledge and making it possible to reduce both functional complaints and depression, the anxiety which accompanies them, to decrease the impact on the quality of life and parental wandering in the installation of adapted accompaniments. For this, a half-day consultation will be intended in order to carry out questionnaires and standardized tests, the results of which will be reported and compared to known rates in the general population and the population of children with chronic diseases.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: QuestionnairesChildren aged 7 to 17 inclusive, and young adults operated (or re-operated) for a Moya Moya in the previous 7 years and followed at the Necker-Enfants Malades hospital, and their parents. |
Who may qualify
- Ages
- 7 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The cohort will be selected from the Necker Hospital cohort (child neurology and neurosurgery services).
Key inclusion criteria (5 listed)
- Adult patients up to 25 years old and minor patients aged 7 to 17 inclusive and holders of parental authority for minor patients
- Patients operated (or re-operated) for a Moya Moya in the previous 7 years
- Subjects without intellectual disabilities
- Subjects speaking French well enough to answer the questions of the study
- subjects (parent(s) and minor or adult patient) and holders of parental authority informed and who do not object to their participation in the study
Key exclusion criteria (1 listed)
- Cognitive level of the patient incompatible with the administration of the questionnaires and evaluations of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuestionnaires are completed only once and assess: * recorded questions about the disease and the operation for the parents and the patient, human figure drawing test and drawing of the operation for the patient * psychiatric questionnaires for parents and patients on anxiety and depression * behavior questionnaires for the parents and the patient: assessment of attachment * questionnaires for the parents and the patient concerning the family context, the quality of life | Other | Patients |
Primary outcome
The " State trait anxiety inventory ", STAI forme Y
Time frame: Day 0
Study the links between postoperative functional disorders by multiple craniotomies in children and adolescents with Moya Moya disease, and psychological dimensions such as anxiety. For teenager, adults patients and parents : The " State trait anxiety inventory ", STAI form Y (revised), a self-questionnaire assessing trait anxiety (usual tendency to be anxious) and state anxiety (anxiety felt at a particular time), has 20 items for assessing trait anxiety and 20 for state anxiety on a 4-point Likert scale, scores range from 20 to 80, with higher scores correlating with greater anxiety.
Revised Children's Manifest Anxiety Scale (RCMAS)
Time frame: Day 0
Revised Children's Manifest Anxiety Scale (RCMAS) : self-administered 37-item questionnaire assessing the level and nature of anxiety in children and adolescents aged 9 to 19, not allowing diagnosis of the various anxiety disorders in children. The total anxiety score can range from 0 to 28. The cut-off point for pathological anxiety is more than two standard deviations around the mean (T more than 70).
Children Depression Inventory (CDI)
Time frame: Day 0
Study the links between postoperative functional disorders by multiple craniotomies in children and adolescents with Moya Moya disease, and psychological dimensions such as depression. CDI Children Depression Inventory : self questionnaire of 27 items which measures the intensity of depression in children and adolescents from 7 to 17 years old. Each item is rated from 0 (normal behavior for age or absent) to 2 (severe). The addition of the items gives a total between 0 and 54. The higher the score, the more severe the depression symptomatology is.
Beck = Depression
Time frame: Day 0
Parents and young adult patients : Beck = Depression Multiple-choice questionnaire of 21 items of symptoms and attitudes, used to measure the severity of clinical depression, graded from 0 to 3 by a series of 4 statements (from 0 to 63, higher score correlating with higher severity) reflecting the degree of severity of the symptom.
FMSS= Five minute speech sample, quality of the parent-child relationship
Time frame: Day 0
The Five Minute Speech Sample (FMSS) is a method that can be used to measure both expressed emotion and narrative coherence. The FMSS requires parents to speak about their child and their relationship with their child for five minutes. The final coding assesses one of two categories: high Expressed Emotions (H EE), or Low Expressed Emotions (Low EE).
Cards for the evaluation of Attachment and Mentalization in Children (CAME)
Time frame: Day 0
Study the links between postoperative functional disorders by multiple craniotomies in children and adolescents with Moya Moya disease, and psychological dimensions such as of attachment of child with parents. CAME: Cards for the evaluation of Attachment and Mentalization in Children, from Child Attachment Interview. The final coding assesses 6 principal dimensions of attachment and 8 secondary dimensions in T quantitative scores. The T scores are scaled so that 50 is average for the youth's age and gender, with a standard deviation of 10 points. Higher scores indicate greater problems. Principal attachment dimensions: Secure (SEC), Insecure-Deactivated (DEAC), Insecure-Hyperactivated (HYP), insecure disorganized (DIS), Mentalized Attachment (MENT-A); the 8 secondary dimensions are: Coherence (COH), Reflective Self (REF-S), Access to Memories (MEM), Mentalization (MENT), Preoccupation/anger (PRE-A), Traumatism (TRAU), Need comfort (COM), Life Difficulties (LIFE-D).
CA-MIR : cards for assessment of parent's attachment
Time frame: Day 0
Cards for assessment of parent's attachment. The final coding assesses 3 principal dimensions of attachment and 13 secondary dimensions in T quantitative scores. The standard scores are scaled so that 50 is average for the youth's age and gender, with a standard deviation of 10 points. Higher scores indicate greater problems. Principal attachment dimensions: Secure (SEC), Insecure- Detached (DET), Insecure- Preoccupied (PRE); the 13 secondary dimensions are : Parental Interference (PAR-I), Family concern (FAM-C), Infantilization Grudge (INF-G), Parental support (PAR-S), Family support (FAM-S), Recognition of support (REC-SUP), Parental unavailability (PAR-UN), Family (FAM-D), Rejection Grudge (REJ-G), Parental Trauma (PAR-TR), Memory Blocking (MEM-B), Parental resignation (PAR-RE), Valuation of Hierarchy (HIE-V).
Child Behavior Checklist (CBCL)
Time frame: Day 0
The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioural problems in children and adolescents. The main scoring for the CBCL is based on statistical groupings of sets of behaviors that typically occur together. Coding assesses 8 syndrome scales:withdrawal, somatic complaints, anxious/depressed, social problems, thought problems, attention problems, rule-breaking behaviour, aggressive behaviour, and two higher order factors: internalizing, and externalizing, and a total score.The standard scores are scaled so that 50 is average for the youth's age and gender, with a standard deviation of 10 points. For each syndrome, Internalizing and Externalizing problem scales, and the total score, scores can be interpreted as falling in the normal, borderline, or clinical behavior.
Representations of disease and surgery
Time frame: Day 0
Human figure drawing test and drawing of the operation for the patient. Recorded questions about the disease and the operation for the parents and the patient. * For the human figure: The Royer grid will allow to define 1) quartiles for the size of the figure according to the age of the child 2) the developmental age for the figure, according to a score varying from 0 to 60. * responses will be qualitatively analyzed to determine prevalent themes.
Pediatric Quality of Life Inventory (PedsQL)
Time frame: Day 0
The Pediatric Quality of Life Inventory (PedsQL) makes it possible to assess the quality of life in relation to the state of health of healthy children or children suffering from various diseases. The 23 questions, each scoring from 0 (never) to 4 (almost always), relate to 4 different areas: the functional physical (8 items, total from 0 to 32), emotional (5 items, total from 0 to 20), social (5 items, total from 0 to 20), and school (5 items, total from 0 to 20). A total score can be calculated (from 0 to 92). 4 versions are proposed, according to the age of the child/adolescent/young adult, each scoring in the same way.
1 secondary outcome
Medical and neuropsychological assessment of patients
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Ouss, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Manoelle Kossorotoff, MD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moyamoya Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 12 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The " State trait anxiety inventory ", STAI forme Y (time frame: Day 0). The study lists 10 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 12 Sep 2025.