Perioperative Evaluation of Cerebellar Tumors

NCT04463979 | Active Not Recruiting

• 1 other identifier: Pro00105872
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebellar Tumors; Brain Tumor

Outcome Measures

Primary Outcomes (2)

• Percentage of cerebellar tumor patients with a positive cerebellar cognitive affective syndrome (CCAS) diagnosis prior to surgery

  CCAS/Schmahmann syndrome scale: 120 point scale (0=most severe cognitive impairment to 120=no cognitive impairment)

  Baseline

• Percentage of brain non-cerebellar tumor patients with a positive cerebellar cognitive affective syndrome (CCAS) diagnosis prior to surgery

  CCAS/Schmahmann syndrome scale: 120 point scale (0=most severe cognitive impairment to 120=no cognitive impairment)

  Baseline

Secondary Outcomes (12)

• Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors

  Discharge (1-2 days after surgery)

• Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors

  1 month after surgery

• Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors

  6 months after surgery

• Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors

  12 months after surgery

• Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors

  18 months after surgery

Study Arms (2)

Cerebellar Tumors

Thirty-three adult (≥18 years of age) patients with primary cerebellar tumors or metastatic tumors located in the cerebellum who will undergo surgery for tumor resection.

Other: Impact of Cerebellar Functional Topography on Cognition and Motor Ataxia

Brain Tumors

Thirty-three adult (≥18 years of age) 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. This group will be included for comparison.

Other: Impact of Cerebellar Functional Topography on Cognition and Motor Ataxia

Interventions

Impact of Cerebellar Functional Topography on Cognition and Motor Ataxia OTHER

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.

Brain Tumors; Cerebellar Tumors

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• ≥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, OR with primary non-cerebellar brain tumors or metastatic tumors located in a non-cerebellar brain location who will undergo surgery for tumor resection

You may not qualify if:

• Patients under the age of 18
• Patients with intracranial pathologies (e.g. stroke, vasculitis, infection, developmental anomalies, etc.) outside of the cerebellum
• Non-oncologic cerebellar pathologies (e.g. stroke, vasculitis, infection, developmental anomalies, primary cerebellar ataxias, etc.)
• Patients who are illiterate, are blind, or do not read or understand English
• Patients with a Karnofsky Performance Status score of equal to less than 40

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Cerebellar Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Infratentorial Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebellar Diseases

Study Officials

• Allan H Friedman, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 9, 2020
• Study Start: February 28, 2021
• Primary Completion: May 16, 2025
• Study Completion (Estimated): May 17, 2027
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)