Clinical trial NCT04688554: Psychosocial, Behavioral, and Radiologic Changes Following Radiosurgery for Benign Neurologic Disease
Official title: Psychosocial, Behavioral, and Radiologic Changes Following Neurologic Events or Interventions: A Prospective, Non-Interventional, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obsessive-Compulsive Disorder
Pain, Intractable
Depression
Keywords: Stereotactic Radiosurgery
Cingulotomy
Capsulotomy
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2020-12-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Describe changes in Obsessive Compulsive Disorder disease burden after stereotactic radiosurgery.
timeFrame: Every 3 months for 1 year or through study completion
measure: Describe changes in Depression disease burden after stereotactic radiosurgery.
timeFrame: Every 3 months for 1 year or through study completion
measure: Describe changes in Pain disease burden after stereotactic radiosurgery.
timeFrame: Every 3 months for 1 year or through study completion
Secondary outcomes:
measure: Describe changes in cognition after stereotactic radiosurgery.
timeFrame: Every 3 months for 1 year or through study completion
measure: Describe changes in radiologic parameters after stereotactic radiosurgery.
timeFrame: Every 6 months for 1 year or through study completion
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Anthony J Cmelak, MD
role: STUDY_CHAIR
References: