Psychosocial, Behavioral, and Radiologic Changes Following Radiosurgery for Benign Neurologic Disease
- Conditions
- Pain, IntractableDepressionObsessive-Compulsive Disorder
- Interventions
- Diagnostic Test: fMRI and DTIBehavioral: Behavioral questionnairesBehavioral: Disease-Specific Patient-Reported OutcomesBehavioral: Behavioral tests
- Registration Number
- NCT04688554
- Lead Sponsor
- Vanderbilt University Medical Center
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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
- Contraindications to MRI of the brain
- Patient declining participation in study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Refractory Depression Behavioral questionnaires fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy Refractory Obsessive Compulsive Disorder Disease-Specific Patient-Reported Outcomes fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical capsulotomy Refractory Tremor fMRI and DTI fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical thalamotomy Refractory Tremor Behavioral questionnaires fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical thalamotomy Refractory Depression Behavioral tests fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy Refractory Obsessive Compulsive Disorder Behavioral questionnaires fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical capsulotomy Refractory Obsessive Compulsive Disorder Behavioral tests fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical capsulotomy Refractory Pain Behavioral questionnaires fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy Refractory Pain Behavioral tests fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy Refractory Depression fMRI and DTI fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy Refractory Obsessive Compulsive Disorder fMRI and DTI fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical capsulotomy Refractory Pain fMRI and DTI fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy Refractory Pain Disease-Specific Patient-Reported Outcomes fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy Refractory Tremor Disease-Specific Patient-Reported Outcomes fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical thalamotomy Refractory Tremor Behavioral tests fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical thalamotomy Refractory Depression Disease-Specific Patient-Reported Outcomes fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy
- Primary Outcome Measures
Name Time Method Describe changes in Pain disease burden after stereotactic radiosurgery. Every 3 months for 1 year or through study completion McGill Pain Scale
Describe changes in Obsessive Compulsive Disorder disease burden after stereotactic radiosurgery. Every 3 months for 1 year or through study completion Yale-Brown Obsessive Compulsive Scale questionnaire
Describe changes in Depression disease burden after stereotactic radiosurgery. Every 3 months for 1 year or through study completion Beck's Depression inventory
- Secondary Outcome Measures
Name Time Method Describe changes in cognition after stereotactic radiosurgery. Every 3 months for 1 year or through study completion Montreal Cognitive Assessment
Describe changes in radiologic parameters after stereotactic radiosurgery. Every 6 months for 1 year or through study completion Brain MRI
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States