Brain Tumor Clinical Trial
Official title:
Perioperative Evaluation of Cerebellar Tumors: Impact of Cerebellar Functional Topography on Cognition and Motor Ataxia
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.
Status | Recruiting |
Enrollment | 66 |
Est. completion date | April 1, 2026 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - =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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors | "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography | Discharge (1-2 days after surgery) | |
Secondary | Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors | "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography | 1 month after surgery | |
Secondary | Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors | "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography | 6 months after surgery | |
Secondary | Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors | "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography | 12 months after surgery | |
Secondary | Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors | "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography | 18 months after surgery | |
Secondary | Neurological Impact of tumor location in patients undergoing resection of cerebellar tumors | "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography | 24 months after surgery | |
Secondary | Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors | "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography | Discharge (1-2 days after surgery) | |
Secondary | Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors | "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography | 1 month after surgery | |
Secondary | Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors | "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography | 6 months after surgery | |
Secondary | Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors | "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography | 12 months after surgery | |
Secondary | Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors | "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography | 18 months after surgery | |
Secondary | Neurological Impact of tumor location in patients undergoing resection of brain non-cerebellar tumors | "Impact" will be determined with standard of care neurological evaluation and "tumor location" with magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography | 24 months after surgery |
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