An observational study in Obsessive-Compulsive Disorder, Pain, Intractable and Depression, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Vanderbilt University Medical Center · Observational
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.
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.
626 studies on the registry are indexed under Obsessive-Compulsive Disorder; 162 are open to participants now.
This study's enrollment of 18 is below the median of 133 across 86 observational studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 159 are open to participants now.
Of its 124 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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
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
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.
Describe changes in Obsessive Compulsive Disorder disease burden after stereotactic radiosurgery.
Yale-Brown Obsessive Compulsive Scale questionnaire
Time frame: Every 3 months for 1 year or through study completion
Describe changes in Depression disease burden after stereotactic radiosurgery.
Beck's Depression inventory
Time frame: Every 3 months for 1 year or through study completion
Describe changes in Pain disease burden after stereotactic radiosurgery.
McGill Pain Scale
Time frame: Every 3 months for 1 year or through study completion
Describe changes in cognition after stereotactic radiosurgery.
Montreal Cognitive Assessment
Time frame: Every 3 months for 1 year or through study completion
Describe changes in radiologic parameters after stereotactic radiosurgery.
Brain MRI
Time frame: Every 6 months for 1 year or through study completion
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Research data will be shared upon reasonable request to the principal investigator.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will become available after the publication of the study results.
Ran from Aug 2020 to primary completion in Feb 2024, 41 months.
Of 26 observational studies under Obsessive-Compulsive Disorder, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 84. This study's 41 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Obsessive-Compulsive Disorder →
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