Skip to main content
OpenTrials
Completed

NCT Number: NCT04688554

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-5671, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fMRI and DTI

Diagnostic Test

Neurologic imaging correlates

Behavioral questionnaires

Behavioral

RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam

Disease-Specific Patient-Reported Outcomes

Behavioral

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

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. Describe changes in cognition after stereotactic radiosurgery.

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

    Montreal Cognitive Assessment

  2. Describe changes in radiologic parameters after stereotactic radiosurgery.

    Time frame: Every 6 months for 1 year or through study completion

    Brain MRI

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Varian Medical Systems

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 30, 2020
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.