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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04688554
Other study ID # 200209
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 25, 2020
Est. completion date August 25, 2025

Study information

Verified date July 2023
Source Vanderbilt University Medical Center
Contact Anthony J Cmelak, MD
Phone 615-322-2555
Email anthony.cmelak@vumc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 25, 2025
Est. primary completion date August 25, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Diagnostic Test:
fMRI and DTI
Neurologic imaging correlates
Behavioral:
Behavioral questionnaires
RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam
Disease-Specific Patient-Reported Outcomes
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
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.

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University Medical Center Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Describe changes in Depression disease burden after stereotactic radiosurgery. Beck's Depression inventory Every 3 months for 1 year or through study completion
Primary Describe changes in Pain disease burden after stereotactic radiosurgery. McGill Pain Scale Every 3 months for 1 year or through study completion
Secondary Describe changes in cognition after stereotactic radiosurgery. Montreal Cognitive Assessment Every 3 months for 1 year or through study completion
Secondary Describe changes in radiologic parameters after stereotactic radiosurgery. Brain MRI Every 6 months for 1 year or through study completion
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