Postual Control in Pediatric Chiari I Malformation

NCT04679792 | Unknown DMC

• 1 other identifier: EquiChiari
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: Chiari I malformation is a rare disease characterized by cerebellar amygdalae descent under the level of the foramen magnum. It causes troubles in cerebrospinal fluid circulation and direct compression on brainstem, producing characteristic headaches, neurological impairment and syringomyelia. Surgery is the only treatment, indicated when symptomatology exists. However, sometimes patients complaint about atypical symptoms that are difficult to interpret. We would like to study one of these atypical symptoms, gait imbalance, in a pediatric population thanks to a computerized dynamic posturography (Equitest®). METHOD: infants from 6 to 18 years of age presenting a radiologically confirmed Chiari I malformation will be included in the study. We will compare posturographic results of patients which will be operated on with the results of the patients which will not; furthermore, we will compare preoperative and postoperative results in operated patients. RESULTS: 19 patients have been enrolled in the study, and data have been collected for 12 of them. Seven patients belong to operated population. CONCLUSIONS: even if enrolment of the patients is satisfactory, disposable data are not enough to perform statistical analysis and to put forward any conclusion.

Conditions

Chiari I Malformation; Pediatric

Outcome Measures

Primary Outcomes (1)

• Composite Equilibrium Score

  Score elaborated by the Equitest posturography

  Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months). Non operated patients: about 4 months for complete evaluation.

Secondary Outcomes (6)

• Cranio cervical MRI

  Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months).

• Medullary MRI

  Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months).

• Apnea syndrome

  Operated patients: from first evaluation to 6 months after surgery (totally: 8-12 months).

• Clinic

  Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months).

• Scoliosis

  Operated patients: from first neurosurgical evaluation to 6 months after surgery (totally: 8-12 months).

Study Arms (2)

operated

Patients Under 18 years of age who are operated for Chiari Malformation on the basis of routine neurosurgical assessment.

Diagnostic Test: Dynamic posturography

non operated

Patients Under 18 years of age who are not operated for Chiari Malformation on the basis of routine neurosurgical assessment.

Diagnostic Test: Dynamic posturography

Interventions

Dynamic posturography DIAGNOSTIC_TEST

Balance evaluation

non operated; operated

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients aged from 6 to 18 years, received for neurosurgical counseling at our institution with a radiologically confirmed Chiari I malformation and presenting ENT symptomes like dizziness, nystagmus, gait imbalance, motion sickness and Chiari not-related migraines. Patients will be selected for surgery in habitual fashion, indipendently on the study. The patients will be divided into 2 groups: patients who will be operated on and patients who won't be operated on.

You may qualify if:

• Radiologically confirmed diagnosis of Chiari I malformation (first MRI realized up to 1/01/2018)
• ENT symptomes (dizziness, nystagmus, gait imbalance, migraines not due to the presence of Chiari Malformation)

You may not qualify if:

• Lack of cooperation (cerebral palsy, severe behavioral troubles, orthopedic illness, severe visual impairment)
• Patient's consent for study non obtained.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• University of Lorraine: collaborator

Study Sites (1)

Stella Irene

Vandœuvre-lès-Nancy, Lorraine, 54500, France

RECRUITING

Related Publications (1)

• Stella I, Remen T, Petel A, Joud A, Klein O, Perrin P. Postural control in Chiari I malformation: protocol for a paediatric prospective, observational cohort - potential role of posturography for surgical indication. BMJ Open. 2022 May 12;12(5):e056647. doi: 10.1136/bmjopen-2021-056647.

  PMID: 35551083 DERIVED

MeSH Terms

Conditions

Arnold-Chiari Malformation

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Perrin Philippe, PhD

  Nancy Regional University Hospital

  STUDY DIRECTOR

Central Study Contacts

Stella Irene, MD

CONTACT

+33383155207; i.stella@chru-nancy.fr

Klein Olivier, PhD

CONTACT

+33383155208; o.klein@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 22, 2020
• Study Start: September 1, 2019
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)