Skip to main content
OpenTrials
Completed

NCT Number: NCT01733173

Functional Imaging of Cerebellar Mutism Syndrome

The purpose of this study is to better understand why some children with cancer have difficulty speaking after brain surgery. Difficulty speaking may be due to known complications to the language centers in the brain. These language centers may be located in slightly different places in different people. This study will study which areas may be damaged.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

3 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject and/or guardian is able to provide written informed consent prior to study registration
  • Age ≥3 years and ≤21 years
  • Newly diagnosed, untreated mass in posterior fossa, either benign or malignant
  • Is being evaluated for surgical resection of the mass
  • Able to perform clinical language testing in English

Exclusion criteria

  • Claustrophobia
  • Any contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander).
  • Pregnant or nursing female
  • Does not speak English as a primary language (as determined by the P.I. or treating physician after discussion with a potential subject and his/her family)
  • Preexisting language or developmental disorder that would limit ability to cooperate with testing (as determined by the P.I. or treating physician after interviewing potential subject and his/her family; for example, a child may be excluded if he/she has confirmed or suspected autism spectrum disorder, dysarthria, dyslexia, lisp, hypotonia, or other age inappropriate speech development)

Treatment and study plan

MRI with DTI and fMRI

Procedure

When possible, the subject will undergo a post operative fMRI/ DTI scan as well as clinical language testing. If the subject develops CMS, the second fMRI will be performed as soon as possible. Some subjects may be severely impaired or have difficulty performing fMRI and clinical language testing tasks. In these instances, the fMRI and language testing may not be performed, or we may choose to perform resting state or passive fMRI tasks instead.

Primary outcomes

  1. investigate the feasibility of performing preoperative fMRI

    Time frame: 1 year

    in young children at risk for developing CMS after posterior fossa brain tumor resection. Age appropriate language functional MRI tasks targeting the cerebellar language centers will be performed in children before surgery and correlated with formal neuropsychological and language testing. The fMRI will be repeated after surgery. If ≥5 of the 7 subjects successfully complete ≥60% of the functional imaging tests, we will determine the pilot study to be successful and then pursue further study.

Secondary outcomes

  1. To investigate potential changes in Diffusion Tensor Imaging (DTI) and tractography

    Time frame: 1 year

    in subjects who develop CMS after brain tumor resection. Injury to cerebro-cerebellar tracts such as the dentatothalamocortical tracts has been implicated in the development of CMS. We propose studying the proximity between important language white matter paths and the surgical intervention before surgery. DTI: Measurements of DTI parameters (e.g., fractional anisotropy, apparent diffusion coefficient) of cerebellar and cerebro-cerebellar white matter tracts on the preoperative scan

  2. To investigate potential changes in DTI after posterior fossa surgery

    Time frame: 1 year

    that may correlate with the development of CMS. We hypothesize that measurements of water diffusion by DTI and tractography will be altered in subjects who develop CMS, even without striking anatomical changes after surgery. DTI: Measurements of DTI parameters (e.g., fractional anisotropy, apparent diffusion coefficient) of cerebellar and cerebro-cerebellar white matter tracts on the postoperative scan. The preoperative and postoperative DTI results will be compared.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Pilot Study: Functional Imaging of Cerebellar Mutism Syndrome

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Nov 26, 2012
Registry last updated
Oct 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.