Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus

Hydrocephalus Clinical Trial

— VINOH  

Official title:

Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus (VINOH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797627
• Other study ID #: 49237
• Secondary ID: 1RC1NS068943-01H
• Status: Completed
• Start date: August 2011
• Est. completion date: August 2016

Study information

• Verified date: January 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This multicenter, prospective study of children with hydrocephalus will examine whether or not ventricle size is associated with poor cognitive outcomes. It is expected that results will indicate larger ventricular size at 6 months after surgery for the initial treatment of hydrocephalus will relate to poorer cognitive outcomes. This study is being conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to conduct multi-institutional clinical trials on pediatric hydrocephalus.

Description:

The current literature is inconclusive regarding the direct association between large ventricle size and poorer cognitive outcomes. This uncertainty stems from relatively few studies, problems with study design (possible confounding factors), varying study populations of hydrocephalus, and conflicting evidence. If the association is proven then aggressive strategies must be developed to maximally decrease ventricular size in these children to preserve long-term cognitive functioning. However, if the association is disproven then previous reservations for procedures such as Endoscopic Third Ventriculostomy (ETV) or higher-resistance shunting to prevent overdrainage complications will be further minimized. Either finding has a major potential to further improve the quality of life in our pediatric hydrocephalus patients. This study is unique as it will include pediatric patients presenting with hydrocephalus from a wide range of etiologies. This study is also unique in that we propose to conduct a brief pre-operative neuropsychological examination to act as internal controls along with the outcomes obtained at a more extensive neuropsychological examination at six months after initial hydrocephalus treatment surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria: Patients will be eligible for enrollment if they:

• are 5 years of age or older; and

• have been newly diagnosed with hydrocephalus to be managed surgically with either a cerebrospinal fluid (CSF) shunt or an ETV; and

• have one of the following etiologies for hydrocephalus: aqueductal stenosis, supratentorial and posterior fossa tumors both benign and malignant, post-traumatic, myelomeningocele, tectal gliomas, post-infectious, and following spontaneous intraventricular hemorrhage (IVH). Malignant tumors have been included as the neuropsychological deficits secondary to adjuvant chemotherapy and radiation have not been demonstrated within the proposed study's 6 month window.

Exclusion Criteria: Patients will be ineligible for enrollment if ANY of the following is true or anticipated:

• present with a Glasgow Coma Scale (GCS) score of less than 14/15, cerebellar mutism, or cognitive deficits so severe as to make neuropsychological testing impossible; OR

• have etiologies of diffuse intrinsic pontine glioma, atypical teratoid rhabdoid tumor, or any tumor with cerebral or spinal metastases (these patients' clinical course and survival are highly unpredictable); OR

• are not expected to survive for 6 months; OR

• are unable or unwilling to participate in the study and with the neuropsychological exam; OR

• due to limitations of neuropsychological testing, blind and deaf children will be excluded. Children for whom English is not their primary language will be included if they have attended 1 or more years of English language based schooling.

Related Conditions & MeSH terms

• Hydrocephalus

Locations

Country	Name	City	State
Canada	Sick Children's Hospital	Toronto	Ontario
United States	Children's Hospital of Alabama, University of Alabama	Birmingham	Alabama
United States	Texas Children's Hospital	Houston	Texas
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Primary Children's Hospital	Salt Lake City	Utah
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	Hydrocephalus Association, National Institute of Neurological Disorders and Stroke (NINDS)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between ventricle size and neuropsychological outcome	Ventricle size, measured as fronto-occipital horn ratio (FOR), as well as neuropsychological outcomes at 6 months post-surgical intervention for initial treatment of hydrocephalus will be compared.	6 months after initial surgical treatment for hydrocephalus
Secondary	Quality of life	The Hydrocephalus Outcome Questionnaire (HOQ) will be administered at approximately 6 months. The HOQ is a validated measure of quality of life specific to the pediatric hydrocephalus population.	6 months after initial surgical treatment for hydrocephalus
Secondary	Academic Performance	Parents will be asked to provide a picture of their child's current academic performance. If available, the child's most recent grade point average (GPA) will be obtained.	6 months after initial surgical treatment for hydrocephalus
Secondary	Presence of additional required hydrocephalus related surgeries	Shunt and ETV revisions or infections will be examined for any correlations with cognitive neuropsychological testing at 6 months from the initial surgical intervention.	6 months after initial surgical treatment for hydrocephalus

External Links

•   Hydrocephalus Clinical Research Network website