Clinical trial NCT05772572: Functional Disorders Moya Moya Young Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moyamoya Disease
Keywords: Moyamoya Disease
Anxiety
Depression
Parent-child attachment
Psychological representations of illness and surgery
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 21
Sex: ALL
Minimum age (years): 7
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort will be selected from the Necker Hospital cohort (child neurology and neurosurgery services).

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

Cognitive level of the patient incompatible with the administration of the questionnaires and evaluations of the study

Primary outcomes:
measure: The " State trait anxiety inventory ", STAI forme Y
timeFrame: Day 0
measure: Revised Children's Manifest Anxiety Scale (RCMAS)
timeFrame: Day 0
measure: Children Depression Inventory (CDI)
timeFrame: Day 0
measure: Beck = Depression
timeFrame: Day 0
measure: FMSS= Five minute speech sample, quality of the parent-child relationship
timeFrame: Day 0
measure: Cards for the evaluation of Attachment and Mentalization in Children (CAME)
timeFrame: Day 0
measure: CA-MIR : cards for assessment of parent's attachment
timeFrame: Day 0
measure: Child Behavior Checklist (CBCL)
timeFrame: Day 0
measure: Representations of disease and surgery
timeFrame: Day 0
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: Day 0
Secondary outcomes:
measure: Medical and neuropsychological assessment of patients
timeFrame: Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Lisa Ouss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Manoelle Kossorotoff, MD
role: STUDY_DIRECTOR
References: