Psychosocial, Behavioral, and Radiologic Changes Following Radiosurgery for Benign Neurologic Disease

NCT04688554 | Completed FDA Device

• 1 other identifier: 200209
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

A number of studies from the literature suggest important behavioral, psychosocial, or radiologic changes occur following significant neurologic events or interventions such as stroke, neurosurgery, medications, radiation, systemic therapy, or injury. The purpose of this study is to describe these changes with advanced neurologic imaging and targeted neurologic and neuropsychiatric assessments. This is a non-interventional observational study of minimal risk to participants as there is no medical intervention. The results of this study will be used to inform patients, scientists, and society in the development of future treatments.

Conditions

Obsessive-Compulsive Disorder; Pain, Intractable; Depression

Keywords

Stereotactic Radiosurgery; Cingulotomy; Capsulotomy

Outcome Measures

Primary Outcomes (3)

• Describe changes in Obsessive Compulsive Disorder disease burden after stereotactic radiosurgery.

  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.

  Beck's Depression inventory

  Every 3 months for 1 year or through study completion

• Describe changes in Pain disease burden after stereotactic radiosurgery.

  McGill Pain Scale

  Every 3 months for 1 year or through study completion

Secondary Outcomes (2)

• Describe changes in cognition after stereotactic radiosurgery.

  Every 3 months for 1 year or through study completion

• Describe changes in radiologic parameters after stereotactic radiosurgery.

  Every 6 months for 1 year or through study completion

Study Arms (4)

Refractory Obsessive Compulsive Disorder

fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical capsulotomy

Diagnostic Test: fMRI and DTI; Behavioral: Behavioral questionnaires; Behavioral: Disease-Specific Patient-Reported Outcomes; Behavioral: Behavioral tests

Refractory Pain

fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy

Diagnostic Test: fMRI and DTI; Behavioral: Behavioral questionnaires; Behavioral: Disease-Specific Patient-Reported Outcomes; Behavioral: Behavioral tests

Refractory Tremor

fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical thalamotomy

Diagnostic Test: fMRI and DTI; Behavioral: Behavioral questionnaires; Behavioral: Disease-Specific Patient-Reported Outcomes; Behavioral: Behavioral tests

Refractory Depression

fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy

Diagnostic Test: fMRI and DTI; Behavioral: Behavioral questionnaires; Behavioral: Disease-Specific Patient-Reported Outcomes; Behavioral: Behavioral tests

Interventions

fMRI and DTI DIAGNOSTIC_TEST

Neurologic imaging correlates

Refractory Depression; Refractory Obsessive Compulsive Disorder; Refractory Pain; Refractory Tremor

Behavioral questionnaires BEHAVIORAL

RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam

Refractory Depression; Refractory Obsessive Compulsive Disorder; Refractory Pain; Refractory Tremor

Disease-Specific Patient-Reported Outcomes BEHAVIORAL

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)

Refractory Depression; Refractory Obsessive Compulsive Disorder; Refractory Pain; Refractory Tremor

Behavioral tests BEHAVIORAL

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; Refractory Obsessive Compulsive Disorder; Refractory Pain; Refractory Tremor

Eligibility Criteria

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

Study Population

VUMC adult patients with neurologic disease or patients with neurologic interventions such as neurosurgical procedures or radiation therapy. Men and women of any ethnicity, race or socioeconomic status who meet inclusion criteria will be offered enrollment into the study. Patient will be greater than 18 years of age and meet inclusion and exclusion criteria. Patients eligible for this study will include patients with neurologic events, including but not limited to stroke, depression, infections, psychiatric disease. Intervention is not part of this study, however, patients receiving neurologic interventions, such as neurosurgical procedures or radiation therapy, would be eligible.

You may qualify if:

• 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

You may not qualify if:

• Contraindications to MRI of the brain
• Patient declining participation in study

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-5671, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Pain, Intractable; Depression

Interventions

Magnetic Resonance Imaging; Diffusion Tensor Imaging; Behavior Rating Scale

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Neuroimaging; Diffusion Magnetic Resonance Imaging; Diagnostic Techniques, Neurological; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Anthony J Cmelak, MD

  Vanderbilt University Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Radiation Oncology

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: December 30, 2020
• Study Start: August 25, 2020
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available after the publication of the study results.

Locations

US (1)