Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus

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Brief Title

Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus

Official Title

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

Brief 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.
    

Detailed 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.
    


Study Type

Observational


Primary Outcome

Association between ventricle size and neuropsychological outcome

Secondary Outcome

 Quality of life

Condition

Hydrocephalus



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

78

Start Date

August 2011

Completion Date

August 2016

Primary Completion Date

July 2016

Eligibility Criteria

        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.
      

Gender

All

Ages

5 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Jay Riva-Cambrin, MD, MSc, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT01797627

Organization ID

49237

Secondary IDs

1RC1NS068943-01

Responsible Party

Principal Investigator

Study Sponsor

University of Utah

Collaborators

 National Institute of Neurological Disorders and Stroke (NINDS)

Study Sponsor

Jay Riva-Cambrin, MD, MSc, Study Chair, Alberta Children's Hospital


Verification Date

January 2020