Psychosocial, Behavioral, and Radiologic Changes Following Radiosurgery for Benign Neurologic Disease
Psychosocial, Behavioral, and Radiologic Changes Following Neurologic Events or Interventions: A Prospective, Non-Interventional, Observational Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Anthony J Cmelak, MD
- Phone Number: 615-322-2555
- Email: anthony.cmelak@vumc.org
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232-5671
- Vanderbilt University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years old and willing and able to sign a written informed consent.
- Eligible for Brain MRI
- History of neurologic event or intervention OR future planned neurologic intervention
Exclusion Criteria:
- Contraindications to MRI of the brain
- Patient declining participation in study
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Refractory Obsessive Compulsive Disorder
fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical capsulotomy
|
Neurologic imaging correlates
RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam
Y-BOCS Survey, QUEST, PDQ39, PHQ2 Depression Screening, PHQ9 Depression Inventory, Beck's Depression Inventory, PROMIS Pain Intensity Short Form 3, McGill Pain Scale, Visual Analog pain scale, FTM (Tremor Scale)
Behavioral tests may include one or more of the following procedures: Upper extremity testing, Perdue Peg Board testing, Hand tactile detection and discrimination test, Temperature and pain threshold testing, Lower extremity Testing, Myomotion Inertial Motion Testing.
|
|
Refractory Pain
fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy
|
Neurologic imaging correlates
RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam
Y-BOCS Survey, QUEST, PDQ39, PHQ2 Depression Screening, PHQ9 Depression Inventory, Beck's Depression Inventory, PROMIS Pain Intensity Short Form 3, McGill Pain Scale, Visual Analog pain scale, FTM (Tremor Scale)
Behavioral tests may include one or more of the following procedures: Upper extremity testing, Perdue Peg Board testing, Hand tactile detection and discrimination test, Temperature and pain threshold testing, Lower extremity Testing, Myomotion Inertial Motion Testing.
|
|
Refractory Tremor
fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical thalamotomy
|
Neurologic imaging correlates
RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam
Y-BOCS Survey, QUEST, PDQ39, PHQ2 Depression Screening, PHQ9 Depression Inventory, Beck's Depression Inventory, PROMIS Pain Intensity Short Form 3, McGill Pain Scale, Visual Analog pain scale, FTM (Tremor Scale)
Behavioral tests may include one or more of the following procedures: Upper extremity testing, Perdue Peg Board testing, Hand tactile detection and discrimination test, Temperature and pain threshold testing, Lower extremity Testing, Myomotion Inertial Motion Testing.
|
|
Refractory Depression
fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy
|
Neurologic imaging correlates
RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam
Y-BOCS Survey, QUEST, PDQ39, PHQ2 Depression Screening, PHQ9 Depression Inventory, Beck's Depression Inventory, PROMIS Pain Intensity Short Form 3, McGill Pain Scale, Visual Analog pain scale, FTM (Tremor Scale)
Behavioral tests may include one or more of the following procedures: Upper extremity testing, Perdue Peg Board testing, Hand tactile detection and discrimination test, Temperature and pain threshold testing, Lower extremity Testing, Myomotion Inertial Motion Testing.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Describe changes in Obsessive Compulsive Disorder disease burden after stereotactic radiosurgery.
Time Frame: Every 3 months for 1 year or through study completion
|
Yale-Brown Obsessive Compulsive Scale questionnaire
|
Every 3 months for 1 year or through study completion
|
|
Describe changes in Depression disease burden after stereotactic radiosurgery.
Time Frame: Every 3 months for 1 year or through study completion
|
Beck's Depression inventory
|
Every 3 months for 1 year or through study completion
|
|
Describe changes in Pain disease burden after stereotactic radiosurgery.
Time Frame: Every 3 months for 1 year or through study completion
|
McGill Pain Scale
|
Every 3 months for 1 year or through study completion
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Describe changes in cognition after stereotactic radiosurgery.
Time Frame: Every 3 months for 1 year or through study completion
|
Montreal Cognitive Assessment
|
Every 3 months for 1 year or through study completion
|
|
Describe changes in radiologic parameters after stereotactic radiosurgery.
Time Frame: Every 6 months for 1 year or through study completion
|
Brain MRI
|
Every 6 months for 1 year or through study completion
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Chair: Anthony J Cmelak, MD, Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 200209
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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