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Clinical Trials/NCT04688554
NCT04688554
Completed
Not Applicable

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

Vanderbilt University Medical Center1 site in 1 country18 target enrollmentAugust 25, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obsessive-Compulsive Disorder
Sponsor
Vanderbilt University Medical Center
Enrollment
18
Locations
1
Primary Endpoint
Describe changes in Obsessive Compulsive Disorder disease burden after stereotactic radiosurgery.
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 25, 2020
End Date
February 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anthony Cmelak

Professor, Department of Radiation Oncology

Vanderbilt University Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Time Frame: Every 3 months for 1 year or through study completion

Beck's Depression inventory

Describe changes in Pain disease burden after stereotactic radiosurgery.

Time Frame: Every 3 months for 1 year or through study completion

McGill Pain Scale

Secondary Outcomes

  • 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 Sites (1)

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