Purpose of the Study: This is a prospective, cohort study to evaluate the impact of
cerebellar functional topography on perioperative outcomes related to cognition and motor
ataxia in patients with cerebellar tumors.
Primary Aim: The primary aim of this study is to determine if patients with a cerebellar
tumor are more likely to test positive for cerebellar cognitive affective syndrome than
patients with non-cerebellar tumors. This information will be used to improve
perioperative assessment in patients with tumors of the cerebellum.
Secondary Aim: To determine the impact of tumor location and cerebellar functional
topography on perioperative outcomes (determined by standard of care neurological
evaluation and brain images) in patients undergoing resection of cerebellar tumors. This
information will be used to improve perioperative assessment in patients with tumors of
the cerebellum.
Study Interventions: Thirty-three adult (≥18 years of age) patients with primary
cerebellar brain tumors or metastatic brain tumors located in the cerebellum who will
undergo surgery for tumor resection, and 33 adult patients with primary non-cerebellar
brain tumors or metastatic tumors located in a non-cerebellar brain location who will
also undergo surgery for tumor resection will be included in this study. The
non-cerebellar brain tumor control group will be included for comparison. Participants in
this study will undergo surgical resection of their cerebellar or brain tumor (as per
standard of care), as well as clinical and radiographic assessment, including:
neurological physical examination (including Karnofsky Performance Scale (KPS) if
conducted per Standard of Care), and magnetic resonance imaging (MRI) with or without
diffusion tensor imaging (DTI)/tractography, prior to, immediately after, at one-month,
6-month, and 1-year follow-up status post-surgical resection. These data will also be
collected at 18-month (±60 days) and 24-month (±60 days) visits post-surgery, if regular
office visits with the neurosurgeon are scheduled at these two time points. Only at
baseline, the following will be conducted: Brief Ataxia Rating Scale (BARS) assessment
score, Cerebellar Cognitive Affective Scale (CCAS/Schmahmann syndrome) scale score,
Montreal Cognitive Assessment (MoCA) assessment, and a quality of life (QoL) assessment
using the SF-36 questionnaire.
Data analysis: For each test item within the CCAS there is a threshold score allowing a
pass/fail determination that differentiates CCAS-positive patients from CCAS-negative
patients. The primary, study endpoint is the percentage of patients with a positive CCAS
diagnosis prior to surgery. The investigators will evaluate whether CCAS is
preferentially seen in association with any demographic or descriptive variables
(particularly tumor location in the cerebellum) using chi-squared testing unless
otherwise indicated. Demographic data including sex, age at time of brain tumor diagnosis
and at surgery, education level completed, and dominant writing hand will be described.
The distribution of each of the following preoperative variables will also be described:
presenting symptom (cognitive, motor, or vestibular), brain lesion type (newly diagnosed
vs recurrent), primary tumor site, primary tumor histology, presence or absence of a
systemic burden of disease, presence of hydrocephalus or previous seizure in 30 days
prior to surgery, prior surgery, prior whole brain radiation or stereotactic
radiosurgery, initiation of antiepileptic or steroids prior to surgery, the indication
for surgery. These data will be used to compare baseline characteristic of cerebellar
tumor patients with non-cerebellar brain tumor patients. All statistical analysis will be
performed by the investigators using Prism 4.0 (GraphPad Software, Inc.) and Stata v10
(StataCorp Lp). Significance will be assessed at alpha = 0.05.
Risks/Benefits: There will be physical or health-related risks to the surgical resection
of the patients' cerebellar tumor according to the standard of care. Risk is also
involved to the extent that privacy and confidentiality may be compromised. However,
every reasonable effort will be made to limit breaches of privacy and confidentiality.
Participants will not benefit directly from this study. However, the results of this work
will help improve the perioperative assessment of patients with tumors of the cerebellum,
which may improve rehabilitation efforts in this unique patient population.
