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Chiari I Malformation clinical trials

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NCT ID: NCT04679792 Recruiting - Pediatric Clinical Trials

Postual Control in Pediatric Chiari I Malformation

Start date: September 1, 2019
Phase:
Study type: Observational [Patient Registry]

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.

NCT ID: NCT01382290 Withdrawn - Tethered Cord Clinical Trials

Magnetic Resonance Imaging of the Spine

MRIS
Start date: March 2008
Phase: N/A
Study type: Interventional

Diffusion-weighted (DW) magnetic resonance imaging (MRI) imaging is a well established method for detecting acute injury to the brain and is used on all children undergoing an MRI brain scan at Children's Healthcare of Atlanta. The possibility of using DW MRI to study other areas of the body, such as the spinal cord, has been recognised as having great clinical potential. However, two main problems have hindered the clinical application of the technique; firstly, the extreme motion sensitivity of the technique meant that respiratory motion have hampered clinical studies. Secondly, the close proximity of the spinal cord to the bones in the spinal column complicates the application of the techniques developed for the brain to the spine. Recently, several techniques have been developed which address these problems and these are now available on the MRI scanners used at Children's Healthcare of Atlanta. We now wish to evaluate how well these techniques work on children in a routine clinical setting. For this reason we wish to add a single scan of the spine to the imaging protocol of children receiving a routine scan of the brain or spine. This will permit us to evaluate the image quality in both normal and abnormal spines. We plan on enrolling 60 patients with normal spines and 30 patients with abnormal spines. No additional sedation and/or contrast will be required and the additional imaging time for the diffusion studies will be less than 10 minutes. Parental consent will be a pre-requisite for any patient to be enrolled into the study.