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Functional Imaging of Cerebellar Mutism Syndrome

Pilot Study: Functional Imaging of Cerebellar Mutism Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01733173
Enrollment
4
Registered
2012-11-26
Start date
2012-11-30
Completion date
2021-10-12
Last updated
2021-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Mass

Keywords

mass in posterior fossa, benign, malignant, surgical resection, MRI, fMRI, DTI, 12-121

Brief summary

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.

Interventions

PROCEDUREMRI with DTI and fMRI

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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 21 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
investigate the feasibility of performing preoperative fMRI1 yearin 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

MeasureTime frameDescription
To investigate potential changes in Diffusion Tensor Imaging (DTI) and tractography1 yearin 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
To investigate potential changes in DTI after posterior fossa surgery1 yearthat 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026