Functional Imaging of Cerebellar Mutism Syndrome

Brain Mass Clinical Trial

Official title:

Pilot Study: Functional Imaging of Cerebellar Mutism Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733173
• Other study ID #: 12-121
• Status: Completed
• Start date: November 2012
• Est. completion date: October 12, 2021

Study information

• Verified date: October 2021
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 12, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 21 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Mass
• Mutism

Intervention

Procedure:
• MRI 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	investigate the feasibility of performing preoperative fMRI	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.	1 year
Secondary	To investigate potential changes in Diffusion Tensor Imaging (DTI) and tractography	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	1 year
Secondary	To investigate potential changes in DTI after posterior fossa surgery	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.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center