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

Study Overview
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Brief Summary
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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.

Detailed Description
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Functional magnetic resonance imaging (fMRI) and diffusion tensor tractography (DTI) have rapidly expanded since its emergence two decades ago. fMRI is well established as the single most powerful method for detecting changes in neural activity in vivo, albeit indirectly by detection of changes in blood oxygenation level dependent (BOLD) signals that reflect hemodynamic changes subsequent to neural activity. A conventional fMRI experiment involves the comparison of two or more brain states followed by statistical tests to identify which brain regions were involved in a particular task. The identification of patterns of highly correlated low-frequency MRI signals in the resting brain provides a powerful approach to delineate and describe neural circuits, and an unprecedented ability to assess the manner in which distributed regions work together to achieve specific functions. Since the first reports of temporal correlations in BOLD baseline signals, several distinct cortical long-range networks have been identified and characterized in the resting state, including a default mode network. Moreover, observations of altered resting state connectivity in several disorders and as a function of behavior or cognitive skills suggest these correlations reflect an important level of brain organization and may play a fundamental role in the execution and maintenance of various brain functions. DTI is also an exceedingly important imaging modality that has elucidated the neural connectivity inherent between various cortical and subcortical structures. DTI is routinely used and has enhanced our understanding of functional connections between various parts of the brain. Prior to interventions, DTI is commonly obtained, so that interventionists can avoid critical circuitry. There is suggestion that both fMRI and DTI imaging is influenced by organic or interventional variables, however this is understudied. The neuroscientists and clinicians would greatly value information that would expand our working knowledge of the basic neural substrates and functional neural changes that occur in patients organically or after interventions. A non-invasive, non-interventional, observational study is needed to show the changes that happen to patients organically or in standard of care settings. A greater working understanding of the neural connectivity and changes that happen in the brain is of great future benefit to patients, science, and society as well as future therapeutic development such as post-stroke care, rehabilitation, post-traumatic brain injury, or post-treatment care in the brain that has previously been influenced by intervention or disease.

Official Title
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Psychosocial, Behavioral, and Radiologic Changes Following Neurologic Events or Interventions: A Prospective, Non-Interventional, Observational Study

Conditions
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Obsessive-Compulsive Disorder, Pain, Intractable, Depression

Intervention / Treatment
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* Diagnostic Test: fMRI and DTI
* Behavioral: Behavioral questionnaires
* Behavioral: Disease-Specific Patient-Reported Outcomes
* Behavioral: Behavioral tests


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Refractory Obsessive Compulsive Disorder<br>fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical capsulotomy | Diagnostic Test: fMRI and DTI<br>* Neurologic imaging correlates<br>Behavioral: Behavioral questionnaires<br>* RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam<br>Behavioral: Disease-Specific Patient-Reported Outcomes<br>* 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)<br>Behavioral: Behavioral tests<br>* 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.<br>|
| Refractory Pain<br>fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy | Diagnostic Test: fMRI and DTI<br>* Neurologic imaging correlates<br>Behavioral: Behavioral questionnaires<br>* RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam<br>Behavioral: Disease-Specific Patient-Reported Outcomes<br>* 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)<br>Behavioral: Behavioral tests<br>* 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.<br>|
| Refractory Tremor<br>fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical thalamotomy | Diagnostic Test: fMRI and DTI<br>* Neurologic imaging correlates<br>Behavioral: Behavioral questionnaires<br>* RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam<br>Behavioral: Disease-Specific Patient-Reported Outcomes<br>* 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)<br>Behavioral: Behavioral tests<br>* 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.<br>|
| Refractory Depression<br>fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy | Diagnostic Test: fMRI and DTI<br>* Neurologic imaging correlates<br>Behavioral: Behavioral questionnaires<br>* RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam<br>Behavioral: Disease-Specific Patient-Reported Outcomes<br>* 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)<br>Behavioral: Behavioral tests<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe changes in cognition after stereotactic radiosurgery. | Montreal Cognitive Assessment | Every 3 months for 1 year or through study completion | 
| Describe changes in radiologic parameters after stereotactic radiosurgery. | Brain MRI | Every 6 months for 1 year or through study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stereotactic Radiosurgery, Cingulotomy, Capsulotomy